Manufacturing Engineer
Bedford, MA based manufacturer of medical device and consumables seeks a dynamic Manufacturing Engineer to provide production guidance for an established 200-employee entrepreneurial organization.
Daily responsibilities will include providing and hands-on support to Medica’s Production group, Materials and Supply Chain team, and Documentation departments. Overall responsibilities include monitoring our manufacturing processes and equipment, identifying process improvements, achieving cost reductions, conducting failure investigations, and communicating issues across all departments.
The ME will participate and lead our continuous improvement effort to deliver outstanding product quality, on-time customer shipments, and achieve other operational KPIs. The incumbent will work under limited supervision but be supported from Medica’s R&D staff of Scientists; Chemists; Electrical, (Bio)Mechanical and Automation Engineers.
This is an exciting and entrepreneurial opportunity for an engaged individual who thrives on successes and desires to grow with Medica as we continue our journey of delivering the world’s best blood gas, electrolyte and chemistry analyzers!
Job Duties required to keep Medica production operational and efficient:
- Maintain and improve product quality and process efficiency.
- Lead continuous improvement, lean manufacturing, and 5S activities.
- Document, qualify, and install new tooling, fixtures, and assembly equipment.
- Utilize databases and analytics for production trends and yield information.
- Specify/build / purchase / install automation equipment on high-volume product lines.
- Identify and resolve manufacturing issues; implement corrective and preventive actions.
- Oversee pre-pilot and pilot lot builds for new products. Perform labor and materials cost analysis.
- Assist with the disposition of non-conforming materials.
- Negotiate with vendors and contractors. Visit vendor sites as needed.
- Evaluate off-site injection mold tooling and assess molder recommendations; confirm vendor tooling and process controls.
- Investigate & recommend substitute materials relating to late deliveries and/or stock-outs.
- Create manufacturing and test procedures. Assist with Production employee training.
- Identify, develop, qualify, and implement cost-saving opportunities.
- Write/approve DCNs, materials dispositions, temporary deviations, and verification reports.
- Eliminate scrap, rework, and material obsolescence through activities to reduce waste.
- Review warranty data and support investigations.
Education:
BS or AS in an Engineering discipline (Mechanical, Industrial, or Manufacturing)
Experience and Skill Requirements:
- 10 years in a production/manufacturing 4.0 environment is desired.
- Process-oriented with solid writing and documentation skills.
- Proficient in MS Excel, Visio, Word, PowerPoint; statical techniques, SQL (desired), Minitab (desired), C++ (desired).
- SolidWorks experience would be beneficial.
- Medical device manufacturing (desired) as well as a basic understanding of GMP’s and ISO requirements.
- Comprehends material properties and plastics molding.
- Experience with programming of PLC’s is desirable; experience with the installation and effective utilization of cobots is desirable.
- A general knowledge of mechanical, electrical, and pneumatic systems.
- Experience with medical device processes including mechanical assembly, liquid filling, labeling, heat-sealing, adhesive bonding, ultrasonic welding, RF welding, barcodes, alarms, and indicating is required.
- Financial skills to present profitable recommendations.
- Excellent communicator and writer; confident decision-maker; individual who always leads by example.
Interested Applicants should forward their resume to:
Mary Williams
VP, Human Resources
Medica Corporation
[email protected]