Medical Device Resume Sample
Selina Thompson
542 Kling Burgs,
San Francisco,
CA
+1 (555) 513 1679
Work Experience
Medical Device Lead Auditors
07/2016
-
PRESENT
Dallas, TX
- Coordinating the packing and shipment of collection containers and labeling/organizing products in the facility’s stock room to simply identification of reprocessed devices
- Utilizing OnDemand to present operational data and management reports as directed by management including facility scorecard to highlight reprocessing savings and waste diversion results
- Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads
- Track nonconforming material and lead Material Review Board (MRB) efforts
- Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing
- Residence in Richmond, VA area
- Provide leadership on a cross-functional project team through all phases of the product development process
Medical Device Operator
01/2010
-
05/2016
Detroit, MI
- Supports and/or leads product changes after launch based on defined needs of the business
- Knowledge of the basic principles in various engineering disciplines
- Education: BS in Engineering, discipline focused in Mechanical, Biomedical, Biomechanical, Material Science, or Chemical Engineering (no Electrical Engineers)
- Relevant experience or Masters in Engineering
- Participate in production decisions concerning new product lines. Use product specifications and release dates to determine resource needs and to aid President in determining product costs
- Coordinate the production aspects for the manufacturing of the product
- Establish and maintain the production schedule for each product to meet established release dates, as well as document and improve the production product development process
- Ensure production schedule is established early and executed in a timely manner
Medical Device Technician
08/2005
-
09/2009
Boston, MA
- Train all new associates on production processes and all associates on new products
- Manage all employees of the cleanroom
- Ensuring full compliance with Radiometers quality system.
- Experience in a product or process development role, preferably with a minimally invasive medical device product company
- Demonstrated technical knowledge of mechanical part design and manufacturing, including silicone and thermoplastic materials, the related tooling and injection molding, thermoforming, extruding and other related process technologies
- Responsible for assisting in, creating and initiating strategies and tactics to increase utilization in the RSM’s sales territory
- Electronically process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations
- Support internal systems, methods, and procedures to maintain compliance
- Develop and maintain product knowledge of CRHF products
Education
Clark University
2000 - 2005
Engineer's Degree in Engineering
Professional Skills
- Knowledge of FDA/QSR requirement & quality systems in Pharma and/or Medical device experience required (i.e. 21 CFR Part 820, Quality System Regulations , 21 CFR Part 803, Medical Device Reporting , The Privacy Rule, HIPAA , ISO 13485)
- Demonstrates excellent customer service and interpersonal skills, both written and verbal
- Outstanding organizational and interpersonal skills in addition to excellent verbal and written communication
- Excellent organizational and problem-solving skills
- Strong problem solving, organizational, communication and analytical skills are required
- Excellent interpersonal and communication skills in French & English (written and verbal)
- Demonstrates organizational skills, accuracy, and attention to detail
How to write Medical Device Resume
Medical Device role is responsible for interpersonal, research, design, health, gmp, analytical, database, training, recruiting, shipping.
To write great resume for medical device job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Medical Device Resume
The section contact information is important in your medical device resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Medical Device Resume
The section work experience is an essential part of your medical device resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous medical device responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular medical device position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Medical Device resume experience can include:
- Continuously undertakes professional development activities to improve skills
- Speaks/presents effectively to both internal and external audiences to influence change and build consensus
- People and team management skills. Ability to lead and challenge multifunctional teams, both external and internal
- Proficient data analysis skills and mastery of statistical tools in problem solving
- Recent Medical Device Validation experience
- Proven experience in the Biomedical device industry
Education on a Medical Device Resume
Make sure to make education a priority on your medical device resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your medical device experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Medical Device Resume
When listing skills on your medical device resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical medical device skills:
- Excellent eye-hand coordination and fine motor skills
- Operates effectively as a leader in assigned roles on projects, or as GTO representative on multiple small teams.
- Flexible and good Communication skills to support a large multidisciplinary team
- Decision-making, in-depth understanding of critical issues, and project management skills required
- Decision making, in-depth understanding of critical issues, and project management skills required
- Effective priority setting
List of Typical Experience For a Medical Device Resume
1
Experience For Medical Device Operator Resume
- Good MS Office experience
- Maintains knowledge of all equipment and related skills
- Experience in high volume injection molding and associated tooling, materials and machinery
- Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Move products from work in process stock to finished goods stock
- Experience in cGMP environment
- Experience in a clinical or regulated environment
- Lean Sigma Experience (Green Belt/Black Belt)
2
Experience For Senior Medical Device Engineer Resume
- Experience with process excellence or a process excellence certification such as Green/Black Belt
- Thorough knowledge of quality systems, Quality by Design, validation, design transfer, and quality engineering principles for devices and combination products
- In proven track record in drug delivery device design, development, and commercial operations
- Ensuring a high quality design history file; leading and authoring technical documentation
- Planning, leading and managing Risk management, Design Verification activities
- Assembling, inspecting, and testing medical devices
- Monitoring Human Factors Engineering activities
3
Experience For Medical Device Lead Auditors Resume
- Applying GMP/GLP requirements to all areas of responsibility
- Leading and/or manage the collaboration with external and internal development partners and stakeholders
- Performing data collection/entry
- Act as a mentor for clinical staff including conducting co-monitoring and training visits
- Ensure clients needs are met while complying with the quality policy program, ensuring the quality policy is implemented and maintained
- A comprehensive understanding of business development, intellectual property, finance, and marketing processes
- Utilizes engineering expertise to develop value-add solutions to customer needs
- Assist with inventory counting activities as required
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
4
Experience For Medical Device Technical Specialist Resume
- Monitor and communicate work progress according to plan
- Monitor, support and challenge technical development as well as testing and verification work
- Excellence in networking across and beyond the company
- Strategic thinking for project direction and strategy
- Knowledge of 21 CFR Part 803, Medical Device Reporting
- Thorough knowledge of industry standards and FDA/EMEA regulatory guidance on combination products and medical devices, specializing in auto injectors
5
Experience For Medical Device Technician Resume
- Understands the big picture, and how activities link to Merck strategy and business goals
- Solicits feedback to ensure that customer/stakeholder needs are the cornerstone of his/her decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems
- This engineer demonstrates the appropriate Culture in interactions with others
- Actively supports and applies the various initiatives and goals of MMD and the company
- Facilitates the re-allocation of roles and responsibilities across team members to facilitate goal achievement and personal development
- Continually improves communication systems and practices within and across teams/units/functions
- Proactively reviews own performance and progress, and seek feedback from manager/peers/stakeholder to close gaps
- Provides candid, timely and tactful communication and feedback to team and collaborators
6
Experience For Associate Medical Device Specialist, Vascular Resume
- Serve as liaison between the customer and various departments
- Manage telephone calls, email and faxes on a daily basis
- Utilize computer, printer, fax machine and scanner when required
- Place the customer first, with full focus on the task at hand
- Communicate service terms or product description(s) clearly. Be sure your company policies, procedures, and services are explained thoroughly to avoid any complications or dissatisfaction arising from unmet expectations
- Process orders, package and ship orders to customers. Shipping is to comply with current DOT regulations. (Training to be provided)
- Maintain implant history records and update in a timely fashion
7
Experience For Medical Device Principal Engineer Resume
- Assist with Regulated Medical Waste pickups when necessary
- Participate in Continuous Improvement projects or events as requested
- Participate in safety audits as required and actively engage in daily safety discussions/observations
- Customer service
- 3) Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project
- Excellent knowledge of ISO 13485 and 14971; IEC 60601 and collateral standards for global products
- Operate in a matrix organization independently
8
Experience For Senior Specialist Medical Device & Combination Products Resume
- 4) Ability to manage routine small projects without assistance
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Convey features and opportunities of study to site
- Collaborate and liaise with study team members for project execution support as appropriate
- Performing both technical and pesonnel aspects of group operations, working within the department or other areas as required, and acting as a technical resource, trainer, and troubleshooter
9
Experience For Medical Device Collection Technician Resume
- Make recommendations for operational and/or technical improvements; coaching and devloping six direct reports, planning and monitoring their workflow, and monitoring data for/and utilizing departmental metrics
- Previous experience with USP , , , , , , EP Plastics (3.1.3, 3.1.4, 3.1.5, 3.1.6, 3.1.7), EP Glass (3.2.1), EP Rubber for Closures (3.2.9), JP Glass (7.0.1), JP Rubber Closures (7.0.3), JP Plastics, ISO 10993 Parts 12 and 18, force testing, and leak testing/CCIT helpful
- Ensuring compliance with internal quality requirements
- Thorough project planning and project leadership
- Previous direct management of the non-leadership employees
- Transfer of Design History File to production
- Monitor CapEx and COGS
- Provide primary packaging and device expertise in broader cross-functional drug product development teams. Proposing, evaluating and challenging technical solutions
- Expert in leading large development projects in complex matrix organization all the way to launch
10
Experience For Medical Device Package Manager Resume
- Hands-on experience in generating documentation (document control) for obtaining CE regulatory approval. Including, Assembling DHF, traceability matrix, risk management file, usability studies, design transfer, etc
- Excellent understanding of EU medical device regulation up to Class IIb devices
- Full expertise in Electronic product lifecycle development from PoC through to Large scale manufacturing
- Cleans, delivers, and performs minor maintenance on distribution medical equipment according to the department policies and procedures
- Performs basic operational checks on all equipment made ready for distribution, including preventative maintenance as needed
- Provide technical inputs in upstream innovation opportunities (e.g. Due Diligences)
- 5) Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements.Search Jobs US
- Performing manufacturing support including: Work Order creation, ERP transactions, Document Review, Change Orders (understanding implementation process), Non-Conforming Reports (initiation/processing), Special Manufacturing Requests (processing)
- Partnering with area and production leaders to track and report team metrics as appropriate including but not limited to: performance to plan, yield and reject trends, inventory levels, area improvement projects
List of Typical Skills For a Medical Device Resume
1
Skills For Medical Device Operator Resume
- In-house or law firm experience within a relevant health care related company with substantive experience in
- Experience with wet chemistry, compendia testing, method development, container closure integrity testing, package engineering
- Experience in primary packaging
- Excellent working knowledge and practical application of GMP for Medical Devices and ISO 13485
- Experience hosting FDA and Notified Body inspections
- Good knowledge of drug development process, clinical trial monitoring procedures, GCP guidelines and medical terminology
- A current valid driver's license, vehicle insurance, clean driving record and ability to travel in own vehicle to designated facility
- A current valid driver's license, vehicle insurance, clean driving record and ability to travel in own vehicle to designated facilities
- Experience working with small parts assembly
2
Skills For Senior Medical Device Engineer Resume
- Previous experience as a Medical Device Technician or in a related role required
- Demonstrated ability to work independently as well as in a team environment required
- Sales or industry related experience and/or education
- Significant experience in the regulations of major markets in the medical device, biologics, pharmaceutical industry, e.g. USFDA cGMPs, EMA
- Significant experience with medical device or combination product commercialization, operations support, and materials/components
- Experience in medical device, pharmaceutical or in biotech organizations
- Experience with Drug Delivery Systems is highly desirable
- Assembling, inspecting, and testing medical device assembly
3
Skills For Medical Device Lead Auditors Resume
- Adapting and having flexibility to move from one manufacturing area to another as needed
- Developing and maintaining biomedical equipment master data to support the Philips InfoView asset management database
- Understanding of CE marking requirements
- Following standard operating procedures (SOP)
- Understanding and modeling the Gore Culture
- Working with EH&S and engineering to ensure a safe work environment
4
Skills For Medical Device Technical Specialist Resume
- Being adaptable and flexible to move from one manufacturing area to another as needed
- Performing medical device assembly, inspection, and testing
- Ensuring the creation of model and device type specific PM checklists where appropriate
- Understanding of statistical techniques and data analysis
- Demonstrating continual improvement in commercial processes
5
Skills For Medical Device Technician Resume
- Calling insurance companies to ensure that the supplies ordered are approved and anauthorization or referral is given
- Providing InfoView support
- Enforcing data standards
- Understanding of QMS systems as applied for electronic medical devices
- Working with small parts
- Manufacturing product with high quality, timeliness and accuracy
6
Skills For Associate Medical Device Specialist, Vascular Resume
- Performing minor equipment maintenance as needed
- Partnering with leadership and team members on area improvement activities
- Significantly contributes to aspects of project management including scope definition, scheduling, budgeting, and contingency planning
- Creating and managing standard device nomenclature in the InfoView asset management database, including key details such as OEM, Current Manufacturer, Device Type, Model Name/Number as well as Hardware and Technology profile information
- Promoting regulatory and industry best practices by validating device-model-data-quality
- Good understanding of pharmaceutical development and manufacturing in general
7
Skills For Medical Device Principal Engineer Resume
- At least five years related experience in bio/pharmaceutical testing or medical device testing industry
- Experience in production operation including managing employees and process implementation
- Experience in high speed automated manufacturing system and trouble shooting is highly desirable
- Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling
- Maintain timely and accurate documentation of all orders, including but not limited to shipping history records and inventory counts
- Embedded technologies, firmware and methods and principles of code development, coding standards, digital to analogue interfacing
- Product design for injection molding/design for manufacture
- Rapid prototyping / mock design for early stage evaluation
- Know-how in microfluidics and/or powder handling
8
Skills For Senior Specialist Medical Device & Combination Products Resume
- Works with manufacturing and suppliers to produce prototypes and leads activities to optimize designs for manufacturability
- Major contributor to Manufacturing technology strategy Industrialization site (resp. Production Site)
- Able to work under pressure and to challenging timelines when needed
- In depth therapeutic and protocol knowledge as provided in company training
- Relevant 3rd level qualification (Scientific, Engineering)
9
Skills For Medical Device Collection Technician Resume
- Able to study manufacturing plans, forecasts, and product specifications to create COGs models
- Connectivity and assembly technology for large volume production
- Used to work with designers and product managers
- Conduct audits of internal and external stakeholders
- Detail-oriented person with an ability to multi-task
10
Skills For Medical Device Package Manager Resume
- Travel 20% of time to conduct audits
- Implementation of strategy, scope, process and programs which drive sales
- Schedule, plan, perform and report audits of clients’ management systems to ensure compliance with regulatory and voluntary requirements
- Define and execute Platform Design and Life Cycle Management Strategy
- Ensure compliance with internal development, commercialization and submission strategies
- Proficient in ERP/MRP systems required related to Master data, BOM’s, production workflows and related topics
- Team oriented with ability to handle multiple tasks and meet deadlines as independent worker, detail oriented and able to juggle multiple tasks at once and be able to maintain professionalism under pressure
- Strong communicator, verbally and in writing
- A current valid driver’s license, vehicle insurance, clean driving record and ability to travel in own vehicle to designated facility
List of Typical Responsibilities For a Medical Device Resume
1
Responsibilities For Medical Device Operator Resume
- Experience in design control, risk analysis and change control management for medical device or combination products and manufacturing systems
- Demonstrated ability to create and translate new ideas into innovative products
- Excellent awareness of commercial aspects of drug/device development processes and the pharmaceutical/biotech industry in general
- Contraceptive devices with and without medicated coating
- Latex dipping and or plastics based technology and its manufacture
- Dry and liquid concentrates for dialysis, chemical cleaning devices/disinfectants, production of purified water
- Drug and biologics product development
- A natural tendency for curiosity and creativity #LI-GZ
- Residence in the Kingman, AZ area
2
Responsibilities For Senior Medical Device Engineer Resume
- Residence in the Traverse City, MI region
- Residence in the Eastern Los Angeles region
- Residence in the Dubois, PA region
- Residence in the Eau Claire, WI region
- Able to be credentialed at the highest level (full vaccinations required, training classes) in order to gain admittance to all required rooms within each designated facility
- Residence in the Sioux City, IA region
3
Responsibilities For Medical Device Lead Auditors Resume
- Residence in the Albany, NY region
- Able to be credentialed at the highest level in order to gain admittance to all required rooms within each designated facility (all vaccinations required, including flu shot)
- Residence in the Toledo, OH region
- Residence in the Youngstown, OH region
- Residence in the Dallas, TX region
- Residence in the San Antonio, TX region
- Residence in the Wausau, WI region
4
Responsibilities For Medical Device Technical Specialist Resume
- Residence in the Guntersville or Crossville, AL region
- Residence in the Grand Rapids / Muskegon, MI area
- Residence in the South Bend, IN region
- Permanent work authorization in the U.S. required
- Residence in the Clinton, IA region
- Residence in the Central Oregon region
- Residence in the Oklahoma City, OK region
- Residence in the Indianapolis region
- Residence in the Philadelphia, PA region
5
Responsibilities For Medical Device Technician Resume
- Residence in the St. Cloud, MN area
- Able to be credentialed at the highest level (training required, vaccinations required) in order to gain admittance to all required rooms within each designated facility
- Residence in Grand Forks area
- Legally authorized to work in the United States without the need for sponsorship now or in the future is required
- Device development knowledge
- Task and Safety oriented
- Can work independently in a team environment
6
Responsibilities For Associate Medical Device Specialist, Vascular Resume
- Takes initiative and proactively seeks quality solutions through continuous improvement
- Knowledge of 21 CFR Part 820, Quality System Regulations
- Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA
- Residence in the North or West Detroit, MI region
- Residence in Dubois area
7
Responsibilities For Medical Device Principal Engineer Resume
- Residence in the Hartford, CT region
- Residence in the Little Rock area
- Residence in the Scottsdale, AZ region
- Residence in the Salem area, central to the various collection sites
- Residence in the region Denver, CO region
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Demonstrated cycles of success in a professional business environment required
- Residence in Nashville area
- Residence in the Orange County region
8
Responsibilities For Senior Specialist Medical Device & Combination Products Resume
- Residence in the Cedar Rapids, Iowa City or Waterloo, IA area
- Residence in the Santa Rosa, CA area
- Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others. Effective written and oral communicator. Able to speak up and contribute in a team forum. Able to apply prior experiences and learning’s in new settings, even if these are unfamiliar
- Strong communication skills both verbal and written including ability to present to Sr. Management and global Health Authorities in support of GMP audits, 510K/BLA approvals
- Demonstrable knowledge of drug delivery devices including auto-injectors, injection pens, reconstitution and dissolution devices, patch/pumps, pre-filled syringes, inhalers or other novel injection technologies
9
Responsibilities For Medical Device Collection Technician Resume
- Experience leading Manufacturing process improvements for efficiencies gains, cost savings initiatives to reduce costs and implement innovations utilizing new technologies
- Is flexible on work hours and travel required to support international manufacturing sites and mold suppliers. Key Relationships / Customer Expectations (Optional) Key Leadership Behaviors (Optional)
- A track record in project or programme management
- Other ophthalmic implants (capsular tension rings, eyelid, stents/shunts etc)
- Surgical instruments and tools indicted for use in the eye
- Ophthalmic - contact lenses, intraocular lenses, other ophthalmic implants (capsular tension rings, eyelid, stents/shunts etc), viscoelastic, ophthalmic solutions, surgical instruments and tools indicted for use in the eye
- Orthopaedic and Dental (O&D) - Orthopaedic implants - specifically joint replacement implants (hip / knee) or spinal devices; Dental implants - titanium screw implants, Guided Tissue Regeneration implants, or dental membranes; General orthopaedic & non-active devices
- Woundcare - films, gels, textile, hydrogels, creams, hydrocolloids, foams, silicone, super absorbers, haemostats, extra cellular matrices and composite dressings
- Active - experience in electro-medical device technical development or testing and an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971
10
Responsibilities For Medical Device Package Manager Resume
- Soft Tissue - breast implants, dural implants, hernia meshes and plugs, prolapse meshes, tissue re-inforcement mesh devices, adhesion barriers, muscular implants, dermal fillers, sutures, surgical sealants, fixation anchors, staple line reinforcements, and scaffolds for tissue regeneration or repair
- Contraceptive - contraceptive devices with and without medicated coating, latex dipping and or plastics based technology and its manufacture, coatings technologycontraceptive, female healthcare products
- Active Implantable (AIMD) - Neuro stimulators, Pace makers, Implantable cardioverter-defibrillator (ICD), Stimulation leads, Infusion pumps, Ventricular assist devices (VAD, LVAD), Artificial hearts, Brachytherapy seeds and delivery systems, Cochlear implants , Implantable sensors, Medical Micro Electro Mechanical Systems (MEMS)
- Hernia meshes and plugs
- Tissue re-inforcement mesh devices
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