Job Description
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
- Lead and mentor a team of manufacturing engineers and equipment technicians to achieve Operations goals.
- Design and develop manufacturing processes, tooling, and fixtures that enhance safety, quality, and productivity. Own line layout and space utilization in all cleanrooms.
- Provide engineering support for equipment qualifications and process validation (IQ/OQ/PQ), including protocol development, execution, data analysis, and reporting.
- Develop work instructions, standards, and process documents, train operators and technicians accordingly.
- Lead root cause analysis and corrective actions for production issues, product defects, customer complaints, and other technical challenges.
- Manage design transfer activities ensuring completion per project plans and meeting production capability targets.
- Drive continuous improvement initiatives to enhance quality, productivity, workflow, reliability, efficiency, and cost savings using tools such as Gage R&R, Cp, Cpk, and SPC.
- Monitor and report manufacturing and quality metrics; support investigations and corrective actions for non-conforming products, CAPAs, and customer returns.
- Collaborate with R&D and Quality to address process performance issues and support prototype, pilot production, and product changes.
- Manage and update manufacturing documentation and ensure process validation for manufacturing transfer and scale-up.
- Support resolution of supply chain and component obsolescence issues, including supplier/customer coordination.
- Assist with regulatory approvals and responses related to existing products.
- Communicate project progress, risks, and recommendations to management proactively.
- Perform additional tasks as needed to support team and organizational success.
EXPERIENCE / SKILL REQUIREMENTS:
Minimum of 7 years of manufacturing engineering experience in a medical device production industry with a minimum of 2 years of supervisory experience.
- Experience with ISO 13485 and FDA Quality System Regulations
- Experience with Minitab or other statistical evaluation software
- Lean Six Sigma training or certification and knowledge of statistical data analysis techniques (DOE, GR&R, Cpk, SPC)
- Risk management experience (DFMEA, PFMEA)
- CAD experience (preferably SolidWorks)
- PD experience is preferred
- Demonstrated project management skills with ability to prioritize multiple concurrent projects in a fast-paced environment and identify/resolve issues as they arise with minimal supervision.
- Cross functional team player with a strong work ethic, strong engineering and problem-solving skills, creative thinking, good decision-making skills, high attention to detail, effective interpersonal skills and excellent verbal/written communication skills.
- Experience with biomedical fiber optic components and processing is a plus.
EDUCATIONAL REQUIREMENTS:
- Bachelor’s degree in mechanical or biomedical engineering (or related Engineering degree) plus minimum of 7 years of experience working in an FDA/ISO regulated medical device/medical equipment industry or equivalent education and years of experience.
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