A bit about us:
We are looking for a candidate with heart valve (or tissue-based device) design and verification/validation testing experience, great understanding of ISO 5840, high proficiency in SolidWorks and CAD, and preferably computational mechanics (FEA or CFD) background.
The Principal R&D Engineer is a member of the Engineering department. The role is involved in designing and developing prototypes of tissue based medical devices and related accessories including – but not limited to – delivery systems. The Principal Engineer is responsible for leading design control projects and risk analyses related to development and performance/safety evaluation.
The Principal R&D Engineer is a member of the Engineering department. The role is involved in designing and developing prototypes of tissue based medical devices and related accessories including – but not limited to – delivery systems. The Principal Engineer is responsible for leading design control projects and risk analyses related to development and performance/safety evaluation.
Why join us?
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Relocation assistance
- Vision insurance
Job Details
We are looking for a candidate with heart valve (or tissue-based device) design and verification/validation testing experience, great understanding of ISO 5840, high proficiency in SolidWorks and CAD, and preferably computational mechanics (FEA or CFD) background.
Duties & Responsibilities: **The ideal candidate will have experience with Class III tissue-based medical device design/testing experience***
Minimum Qualifications
Preferred Qualifications:
Duties & Responsibilities: **The ideal candidate will have experience with Class III tissue-based medical device design/testing experience***
- Build, design, and test innovative ideas and iterations for our portfolio of products.
- Develop design control plans related to tissue based devices and related accessories in accordance with 21 CFR 820.30
- Identify performance testing required to ensure device safety/efficacy
- Work cross-functionally with Clinical Affairs and clinicians to ensure Human Factors Engineering is incorporated into device design
- Develop manufacturing Work Instructions
- Ability to apply advanced mathematical and computational models to design related activities.
- Identify vendors to develop custom components
- Perform dimensional inspection on critical components
- Work with Quality to ensure appropriate QC activities are identified to ensure device safety
- Own Engineering CAPAs, NCRs, Observations, as appropriate and assigned by management
- Create protocols and reports for studies performed in-house and externally (e.g., FEA, corrosion, AWT, etc.)
- Perform risk assessment (e.g., FMEA, etc.)
- Mentor junior staff
Minimum Qualifications
- Experience in design and development of bioprosthetic valves and related accessories
- B.S. in Biomedical Engineering or similar: 10+ years’ industry experience (7+ years’ with MS and 5+ years with PhD)
- Strong understanding of the anatomy and functionality of the vascular and cardiac system
- Strong understanding of ISO 5840, ISO 14971, ISO 22442-1 and design controls requirements per 21 CFR 820.30, 2017/745/EU
- Experienced in risk analysis
- Excellent understanding of mathematical and computational modeling
- Advanced proficiency in SolidWorks and CAD drawings
- Organized and team-oriented
- Fluent in verbal and written English
Preferred Qualifications:
- Strong understanding of FEA and computational modeling
- Strong understanding of properties of processed and unprocessed tissues