Payrate: $50.00 - $56.00/Hour

Responsibilities Include:

• Understanding of Medical Device-New product development and Sustaining Engineering Process
• Working knowledge of technical files and Medical Device product development process
• Knowledge of current European Medical Device directives (MDD/MDR) and CE Mark process, Experience in Remediation of QMS, Tech File, DHF and Risk Management File
• Understanding of Medical regulatory standards is preferred (EU Regulations MDD & MDR)
• Knowledge on Part 820, Part 11, ISO 13485, MDD/IVDD, IEC 60601x, IEC 62304, ISO 14971
• Knowledge in DFMEA, PFMEA, GD&T and Design documentation processes, Experience in creation of Protocols, Testing and Verification including product usability is required
• Hardworking and should be individual in design activity and Problem-solving skills
• Should have good communication skills to be able to communicate with steak holders, project managers, outside vendors, Experience with MS Project, MS Office.

Qualifications:

• Minimum 5 years’ experience in mechanical design, new product development of medical devices, or sustaining engineering
• Bachelor’s degree in engineering or similar engineering discipline (master’s degree in mechanical or biomedical engineering preferred)
• Experience in EUMDR product remediation is a plus

Must Have Skill:

• Engineering Degree BS at least,
• Min 5 years of Med Device Experience preferred
• at least 3 years working for product development
• Understanding med device V&V process,
• Experience in EUMDR remediation PD work

Nice to have Skills:

• Knowledge of requirement trace to site inputs
• Drafting protocols
• Data analysis
• Test methods and test validations
• 3-4 years direct R&D experience

Pay Transparency: The typical base pay for this role across the U.S. is: $50.00 - $56.00 per hour. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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