Our rapidly growing emerging business is looking for a Medical Device Design Assurance Engineering contractor to help us accelerate our entry into a new market. This role will initially focus on expediting technical work related to medical device remediation and may expand to support development engineering, pilot manufacturing quality initiatives and post market design changes/improvements. You will be embedded in an emerging business with a focus on creating new to the world products to help people hear better.
Responsibilities:
- Review, build and edit technical files and design control documents for medical devices with integrated hardware and software in accordance with QMS system
- Prepare and review design verification test protocols, procedures, and reports
- Drive risk management file activities and updates inclusive of hazard analysis and DFMEAs and the inform risk management approach for engineering
- Assist engineering in the compilation of design history files to align with ISO 13485, ISO14971 Risk Management and IEC 60601 or other applicable USFDA and EUMDD regulations
- Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the QMS
- Support potential CAPAs and audits (internal and external)
Qualifications:
- BS in Engineering, Bioengineering with at least 3 years of experience working in medical devices
- Experience in product & process development
- Proficient with medical device product and process risk management as well as regulations and standards under USFDA and EUMDD
- Technical skills in test method development and validation
- Comfortable with Microsoft Office
- Team oriented with strong communication and mentoring skills
