Tewksbury MA: Sr Manufacturing / Process Engineers (MEDICAL DEVICES / ONSITE) (232666)

Engineering Services | Hardware Engineering | Software Engineering

Job Description 

Product Development on a Injected Molded disposable medical device

Primary Responsibilities

• Ensure manufacturing processes are in conformance with ISO and FDA guidelines.
• Support/lead programs for cycle time/cost reductions, safety initiatives and quality improvements.
• Establish controls for manufacturing to ensure repeatability and quality of process outputs.
• Research, source, and specify equipment as it relates to manufacturing processes.
• Generate equipment specifications and equipment acceptance criteria.
• Provide Design for Manufacturing/Design for Test (DFx) guidance for incorporating into designs.
• Interface with R&D and marketing to effect product design changes that aid manufacturing.
• Plan, author and execute process validations and equipment qualifications.
• Troubleshoot and resolve manufacturing process issues via clear and rational root cause analysis.
• Provide guidance and training to less experienced engineers for CAPA and complaint handling.
• Provide manufacturing direction and guidance to R&D, QA engineers and technicians.
• Perform lead role in transitioning new designs into manufacturing
• Creates project plans and organizes resources to ensure project milestones and costs are met
• Provide training to production personnel on manufacturing processes.
• Revise and improve SOP’s.

Knowledge, Experience and Education Requirements

• Bachelor’s Degree or equivalent, in a technical field; with Manufacturing, Mechanical, Electrical, or Industrial engineering degrees preferred.
• 7-10 years related experience with a wide range of engineering, design, and computer skills.
• Thorough knowledge of FDA Quality System Regulations and ISO Quality Systems Requirements.
• Leadership skills to teach, train, and lead others in the manufacturing process.
• Expertise with SPC, Experimental Design and Statistical Sampling techniques.
• Advanced SolidWorks capability is preferred.
• Fabrication skills are preferred.
• Aptitude for leading/managing people is preferred (career growth).-

BSME, Process Development, Medical Devices

Tewksbury MA: Sr Manufacturing / Process Engineers (MEDICAL DEVICES / ONSITE) (232666)


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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