Our client in Bedford, Ma is looking for a Manufacturing Engineering Manager to join their team. 

The Manufacturing Engineering Manager will lead and direct a manufacturing engineering team that provides hands-on engineering support to Manufacturing, Quality Control, Materials, and Documentation. Responsibilities include: quality and process improvements, cost reductions, failure investigations, and problem resolution. Actively participate in continuous improvement and lean manufacturing efforts to improve quality, performance and costs. Provide technical leadership and coaching to team of engineers and technicians.

Job Duties:

·        Identify and prioritize opportunities for improvements, resolve inter-disciplinary issues, and implement corrective, preventive, and cost-saving actions

·        Oversee and improve manufacturing processes, equipment, and documentation – including procedures, drawings, bills of material, work cell layout, etc.

·        Lead a team to support Operations. Team responsibilities include:

o  Troubleshoot electro-mechanical systems, resolve problems, and develop/implement means to prevent their recurrence.

o  Basic understanding of reagent handling and mixing.

o  Document, qualify, and implement tooling, fixtures, and assembly/test equipment.

o  Reduce scrap, rework, and inspection time through engineering activities to improve process and product reliability.

o  Collaborate with R&D to ensure new products are ready for manufacturing

Education:

MS or BS in an Engineering discipline (Biomedical, Chemical Engineering, Electrical, Mechanical, Industrial, or Manufacturing most relevant), with at least 8 years relevant engineering experience.

Experience and Skill Requirements:

·        Must have strong leadership and communication skills.

·        Must be well-rounded systems- and process-oriented engineer with medical device manufacturing and/or design experience.

·        Experience with implementation of Lean Manufacturing principles

·        Must have good analytical, quantitative, and writing skills.

·        Experience using SolidWorks is highly desirable.

·        A general knowledge of mechanical/ electrical/ pneumatic equipment and mfg./ test processes is highly desirable. Typical processes include: mechanical assembly, liquid filling, heat sealing, ultrasonic welding/sealing, RF welding/sealing, adhesive bonding, leak / flow testing, and labeling.

·        Excellent writing and verbal communication skills are required, as well as understanding of cGMP’s, ISO 13485 and 21 CFR Part 820 requirements.