Engineering Manager
We are seeking a results-driven Engineering Manager to lead a multidisciplinary team in the design, development, and manufacturing of innovative medical devices. This role is critical to ensuring engineering excellence, regulatory compliance, and cross-functional collaboration throughout the product lifecycle.
Key Responsibilities
- Lead and mentor a team of engineers across mechanical, electrical, and manufacturing disciplines.
- Oversee design control activities in accordance with FDA, ISO 13485, and other applicable standards.
- Drive execution of product development projects from concept through commercialization.
- Collaborate with Quality, Regulatory, Operations, and Marketing to ensure successful product launches.
- Manage engineering resources, budgets, and timelines to meet business objectives.
- Support continuous improvement initiatives using Lean, Six Sigma, and other methodologies.
- Ensure robust documentation including DHF, DMR, and risk management files.
- Evaluate and implement new technologies, tools, and processes to enhance product performance and manufacturability.
Qualifications
- Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field); Master's preferred.
- 7+ years of experience in medical device engineering, with at least 2 years in a leadership role.
- Strong understanding of design controls, validation (IQ/OQ/PQ), and regulatory requirements.
- Proven track record of leading cross-functional teams and delivering complex projects.
- Excellent communication, organizational, and problem-solving skills.
Preferred Skills
- Experience with Class II or III medical devices.
- Familiarity with CAD tools, ERP systems, and PLM platforms.
- Certified Six Sigma Green or Black Belt.
- PMP or similar project management certification.
What We Offer
- Competitive compensation and benefits package.
- Opportunity to work on life-changing technologies.
- Collaborative and mission-driven culture.
- Professional development and growth opportunities.
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