Sr. R&D Engineer

R&D And Quality Engineer

Responsible for providing R&D and quality engineering support to ensure the successful development of Mini Med devices, design transfers, scale-up and ongoing operational support. Work with Design and Quality control on product design, verification and validation testing, test method development, and manufacturing transfer support for Class II and Class III medical devices. Perform prototyping/fixture creation and design documentation. Navigate complex regulations and standards including FDA Quality Systems Regulations (QSR) 21 CFR 820, ISO 13485, ISO 10993-1, and American Society for Testing and Materials (ASTM) D4169.

Responsible for pre and post Market risk analysis activities including Fault Tree Analysis, Process and Design Failure Mode Analysis (PFMEA and DFMEA), and Corrective and Preventative Actions (CAPA). Analyze post-market surveillance data, investigate and respond to complaints. Coordinate Design of Experiments (DOE) based on knowledge in Sampling Techniques and Statistical Analysis. Responsible for the development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) and Gage R&R.

Utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in association with technical report creation and Engineering Change Order (ECO) routing. Leverage 2D Drafting and 3D Modeling using CADs software for design of robust and manufacturable device components including plastic injection molding, utilizing Solid Works and Geometric Dimensioning and Tolerancing (GD&T) application. Position works a hybrid model and will be onsite at the San Diego, CA location 4 days per week.

Salary: $105,000 - $125,000.

Requires a Master's degree in Mechanical, Industrial, Chemical or Biomedical Engineering or related engineering field plus two (2) years of experience in R&D Engineer or related occupation for medical devices.

Must possess at least two (2) years' experience with each of the following:

• Product design, verification and validation testing, test method development, and manufacturing transfer support for Class II and Class III medical devices;
• Prototyping/fixture creation and design documentation
• FDA QSR 21 CFR 820, ISO 13485, ISO 10993-1, and ASTM D4169.
• Risk analysis activities including Fault Tree Analysis, PFMEA, DFMEA, and CAPA
• Analyzing post-market surveillance, investigating and responding to complaints
• DOE, Sampling Techniques, and statistical analysis
• IQ/OQ/PQ and Gage R&R
• ECOs, technical reports, and compliance with GMP and GDP.
• 2D Drafting and 3D Modeling using CADs software for design of robust and manufacturable device components including plastic injection molding, utilizing Solid Works, GD&T application.

Benefits & Compensation

Mini Med offers a competitive salary and flexible benefits package.

At Mini Med, we put people first. A commitment to our employees lives at the core of our values:
We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

Salary range for U.S. (excl. PR) locations (USD): $ to $

Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

At Mini Med, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account.

In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our…