OVERVIEW:
Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Packaging Engineer.
Position: R&D Engineer II
Location: Brea CA 92821
Duration: 12 Months contract with possible extension
Pay Rate: $45/hr - $51/hr (depending on experience)
Job Requirement:
- Hybrid, expectations are onsite MT and TH with the availability to be in WF if need be
- 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
- Innovation: Identifies external technologies, Identifies critical strengths and weaknesses, Nurtures IDR's (Invention Disclosure Records) from infancy, Continuous Learning
- Participates in external activities to enhance the brand recognition of BD by writing papers and generating IP (Intellectual Property)
- Accountability: strong and clear accountability for the successful and timely achievement of goals.
- Ability to assess project / program needs, engage team members, build support, and execute; proactively identify and mitigate risks.
- Hold and encourage frequent formal and informal communication within the team and the rest of the organization to ensure dissemination of important information.
- Recommendations to decision making committees.
- Resolves conflicts within team by facilitating communication.
Job Requirement:
- 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.
I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you.
SB
Job Types: Full-time, Contract
Pay: $45.00 - $51.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Experience level:
Schedule:
- 8 hour shift
- Monday to Friday
Education:
Experience:
- Medical Devices: 2 years (Required)
- Design Control: 1 year (Required)
Ability to Commute:
- Brea, CA 92821 (Required)
Work Location: In person