Position Overview
We are seeking a proactive and detail-oriented Manufacturing Engineer to bridge the gap between Engineering and Production in an ISO 13485–compliant medical device manufacturing environment. The ideal candidate will develop and maintain robust manufacturing processes and documentation, ensuring product reliability, regulatory compliance, and operational efficiency.
Essential Job Functions
Process Development & Documentation
- Create and maintain manufacturing routers, work instructions, and standard operating procedures (SOPs).
- Develop and update process flow charts and PFMEAs.
- Lead and support process validations (IQ/OQ/PQ) in accordance with ISO 13485 and FDA requirements.
- Conduct First Article Inspections (FAI) and ensure proper documentation and traceability.
- Collaborate with Quality to develop and maintain Production Part Approval Process (PPAP) documentation.
- Evaluate existing tools and fixtures for effectiveness; design and create new ones using SolidWorks or equivalent software.
Inspection and Quality Control
- Design and implement incoming inspection procedures for raw materials and components.
- Monitor and analyze non-conforming materials, lead root cause investigations, and define rework processes.
- Support and participate in Corrective and Preventive Actions (CAPA).
- Conduct and analyze Statistical Process Control (SPC) studies to monitor and improve process performance.
Training and Support
- Train production personnel on new or revised manufacturing procedures and equipment.
- Provide technical support to resolve production issues and improve process capability.
Continuous Improvement
- Collaborate with cross-functional teams to identify and implement process improvements.
- Lead initiatives to reduce waste, enhance efficiency, and improve overall manufacturing performance.
Required Qualifications
- Bachelor’s degree in Mechanical, Manufacturing, Biomedical Engineering, or a related field.
- Minimum of 3–5 years of experience in a regulated manufacturing environment, preferably in medical devices.
- Strong working knowledge of ISO 13485 and FDA manufacturing standards.
- Experience with process validation, FAI, PFMEA, SPC, and PPAP documentation.
- Proficiency in CAD software (e.g., SolidWorks), ERP systems, and Microsoft Office Suite.
- Excellent documentation, communication, and organizational skills.
Preferred Skills
- Familiarity with risk management tools and statistical analysis software (e.g., Minitab).
- Demonstrated experience driving process improvement and cost reduction initiatives.
Training
- As defined within the company’s training matrix and quality management system.
Disclaimer
Employees must be able to perform the essential functions of this position satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions, provided such accommodations do not impose undue hardship.
This job description is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.
The company is an Equal Opportunity Employer and complies with all applicable federal and state employment laws.
Job Type: Full-time
Pay: $90,000.00 - $125,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
