Product Developer
Job Description
A-Line is now sourcing an Product Developer in Brea CA (92821). The Product Developer would be working for a Fortune 500 company and has career growth potential. This would be full time / 40+ hours per week.
If you are interested in this Product Developer position, please apply here or contact Mia Garrett at Mgarrett@alinestaffing.com or 586-422-1209.
Product Developer Compensation
- Annual Pay Rate: $47.22/hour
- Benefits are available to full-time employees after 90 days of employment
- A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates
Product Developer Highlights
- Shift Notes: 8:00a-5:00p Monday-Friday.
- Friday will be remote with some on site days as needed.
Product Developer Responsibilities
While maintaining a Customer Focus, responsibilities include (but are not limited to): Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation and Design Transfer activities.
The R&D Engineer II will impact healthcare business groups by engaging in commercialization of new products and design changes for current products through development, qualification and launch phases.
The R&D Engineer II contributes to building organizational effectiveness through creating, leveraging and sharing best practices; seeking and providing training; driving technical and workflow innovation.
- Design control understanding and adherence
- Supporting Design Verification strategy development
- Supporting Desing Validation strategy development
- Creating, editing, and interpreting technical drawings
- Functional Device Testing
- Testing by Analysis
- End User Validation Testing
- Technical writing (protocols, reports, work instructions, presentations, etc.) and effective verbal communication
- Application of engineering principles for design / analysis
- Statistical analysis and sample plan development
Product Developer Requirements
- Bachelor’s Degree in Mechanical or Biomedical Engineering with a min. of 3+ years of experience in medical device or other regulated industry OR Advanced Degree in Mechanical or Biomedical Engineering.
- Track record of technical problem solving and effective product development.
- Design controls expertise for Medical or regulated industry experience.
- Design Verification experience, (Protocol Generation, Report Writing, Testing Strategies)
- Proficient in statistical methods / tools
- Proficient in solid mechanics / mechanics of materials
- Familiarity with traditional and modern fabrication techniques
- Knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO14971 and ISO 80369 and collateral standards.
- Preferred Qualifications and Knowledge:
- Graduate degree (MS) in Mechanical Engineering, Biomedical Engineering or similar
- 3+ years of post-educational experience in Medical Device
- Sought as an SME (Subject Matter Expert) in one or more areas expertise
If you think this Product Developer role is a good fit for you, feel free to call, e-mail, or apply to this posting!
Mia Garrett – Recruiting Assistant Mgarrett@alinestaffing.com or 586-422-1209