MDA Edge
Medical Device Senior Manufacturing Engineer
3 weeks ago Be among the first 25 applicants This range is provided by MDA Edge. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$60.00/hr - $65.00/hr Job Summary:
The hiring manager is specifically seeking candidates with hands-on experience in
cart systems, console operations , and
electromechanical devices.
This includes hands-on experience in troubleshooting, maintaining, and optimizing these systems in a mechanical and electrical integration environment.
Key Skills:
Medical Device Manufacturing, Design for Manufacturing (DFM), SolidWorks, Process Validation, New Product Development, Statistical Analysis Software, Vendor Management. Work Hours Per Week:
35 Work Hours Per Day: 7 Responsibilities:
Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging. Produce production-level assembly and part drawings for all components and sub-assemblies. Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency through activities like DFMA reviews and cycle time optimization. Proactively identify and evaluate potential contract manufacturing partners by analyzing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers. Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships. Act as the liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities as directed by Management. Review engineering product specifications and CAD data/drawings as part of the design review process to ensure they meet industry and manufacturing standards and practices. Responsible for part/drawing release and the accuracy of the Bill of Materials (BOM). Drive the development and execution of complex experiments and tests (including writing and executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports. Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing. Deploy manufacturing risk assessment and mitigations, including hands-on and resourceful action plans. Developing and maintaining manufacturing work instructions, equipment instructions, and other documents that require quality management system controls. Coordinating technical communications between Canon and contract manufacturers, including design transfer. Providing technical expertise in conducting pFMEA and developing process validations. Sharing expertise in Lean Six Sigma process excellence principles. Collaborating with cross-functional product development teams, including project managers, optical engineers, mechanical engineers, electrical engineers, software engineers, quality engineers, regulatory specialists, clinical specialists, marketers, buyers, and others. Results Expected:
Development and maintenance of project task list for DFM Activities. Create and maintain up-to-date BOMs, work instructions, and travelers. Creation and maintenance of pFMEA. Basic Qualifications:
Education:
Bachelor's degree or higher in Mechanical engineering. 5+ years of experience in medical device manufacturing engineering, including at least three years in new product development, design transfer to production, and validating processes. Excellent modeling and drawing skills using
SolidWorks , including proficiency with assemblies that contain dozens of parts. Experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred. Proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques. Technical expertise in
DFM, Six Sigma, LEAN, cGMP, and process validation. Proficient in
SolidWorks
with experience in tool and fixture design. Highly proficient in Microsoft Office Suite and statistical analysis software like
Minitab or JMP for
process monitoring and improvement Nice to Haves:
Lean and/or Six Sigma certifications preferred.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at MDA Edge by 2x Get notified about new Senior Manufacturing Engineer jobs in
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3 weeks ago Be among the first 25 applicants This range is provided by MDA Edge. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$60.00/hr - $65.00/hr Job Summary:
The hiring manager is specifically seeking candidates with hands-on experience in
cart systems, console operations , and
electromechanical devices.
This includes hands-on experience in troubleshooting, maintaining, and optimizing these systems in a mechanical and electrical integration environment.
Key Skills:
Medical Device Manufacturing, Design for Manufacturing (DFM), SolidWorks, Process Validation, New Product Development, Statistical Analysis Software, Vendor Management. Work Hours Per Week:
35 Work Hours Per Day: 7 Responsibilities:
Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging. Produce production-level assembly and part drawings for all components and sub-assemblies. Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency through activities like DFMA reviews and cycle time optimization. Proactively identify and evaluate potential contract manufacturing partners by analyzing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers. Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships. Act as the liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities as directed by Management. Review engineering product specifications and CAD data/drawings as part of the design review process to ensure they meet industry and manufacturing standards and practices. Responsible for part/drawing release and the accuracy of the Bill of Materials (BOM). Drive the development and execution of complex experiments and tests (including writing and executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports. Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing. Deploy manufacturing risk assessment and mitigations, including hands-on and resourceful action plans. Developing and maintaining manufacturing work instructions, equipment instructions, and other documents that require quality management system controls. Coordinating technical communications between Canon and contract manufacturers, including design transfer. Providing technical expertise in conducting pFMEA and developing process validations. Sharing expertise in Lean Six Sigma process excellence principles. Collaborating with cross-functional product development teams, including project managers, optical engineers, mechanical engineers, electrical engineers, software engineers, quality engineers, regulatory specialists, clinical specialists, marketers, buyers, and others. Results Expected:
Development and maintenance of project task list for DFM Activities. Create and maintain up-to-date BOMs, work instructions, and travelers. Creation and maintenance of pFMEA. Basic Qualifications:
Education:
Bachelor's degree or higher in Mechanical engineering. 5+ years of experience in medical device manufacturing engineering, including at least three years in new product development, design transfer to production, and validating processes. Excellent modeling and drawing skills using
SolidWorks , including proficiency with assemblies that contain dozens of parts. Experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred. Proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques. Technical expertise in
DFM, Six Sigma, LEAN, cGMP, and process validation. Proficient in
SolidWorks
with experience in tool and fixture design. Highly proficient in Microsoft Office Suite and statistical analysis software like
Minitab or JMP for
process monitoring and improvement Nice to Haves:
Lean and/or Six Sigma certifications preferred.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at MDA Edge by 2x Get notified about new Senior Manufacturing Engineer jobs in
Cambridge, MA . Senior Advanced Manufacturing Engineering Manager
Manufacturing Engineering Manager - Optics & Lasers
Sr Manager, Manufacturing Cost of Quality
Production Manager / Manufacturing Manager
Principal Product Manager, AI Manufacturing
Sr Manager, Risk Remediation (Medical Equipment Manufacturing)
Bedford, MA $190,000 - $230,000 4 days ago Human Resources Manager - Union Manufacturing
Quincy, MA $114,000 - $171,000 2 weeks ago Human Resources Manager - Union Manufacturing
Tax Manager - Manufacturing/Distribution
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr