Engineering Laboratory Manager (Medtech)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Engineering Laboratory Manager (Medtech): Leading the engineering lab team in the development, maintenance, and continuous improvement of medical devices with an accent on sustaining support, prototyping, and design verification. Focus on managing technical resources, ensuring regulatory compliance (FDA/ISO), and mentoring a team of engineers and technicians to optimize quality and efficiency.
Location: Must be based in Kennewick, WA (Onsite)
Salary: $140,000 - $165,000 USD
Company
is a developer of cutting-edge medical devices focused on high-quality engineering and regulatory excellence.
What you will do
- Oversee and lead the Engineering Laboratory team in supporting new development and post-release sustaining activities.
- Provide mentorship and technical guidance to Laboratory Technicians and Engineers to foster professional growth.
- Manage laboratory resources, schedules, and priorities to ensure efficient project execution.
- Lead engineering change control efforts and coordinate cross-functionally with Production, Procurement, and Manufacturing.
- Ensure all laboratory processes, systems, and outputs align with FDA 21 CFR Part 820 and ISO 13485 standards.
- Partner with internal departments and external vendors to resolve engineering escalations and maintain design quality.
Requirements
- B.S. in Electrical Engineering or equivalent experience.
- 10+ years of relevant professional engineering management experience.
- Comprehensive knowledge of PCB design, DFM/DFT, and hardware development life cycles.
- Thorough understanding of regulatory compliance and QMS in a medical or highly regulated industry.
- Ability to work onsite in Kennewick, WA.
Culture & Benefits
- Opportunity to lead technical teams in a safety-conscious, highly regulated medical device environment.
- Focus on continuous improvement of engineering processes and systems.
- Collaborative work environment partnering with cross-functional teams including Regulatory Affairs and Quality Assurance.
- Equal Opportunity Employer committed to an inclusive workplace.
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