Medical Device Senior Manufacturing Engineer

MDA Edge

Cambridge (MA)

On-site

USD 82,656 - 89,544

Full time

14 days+

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Job summary

An established industry player is seeking a Senior Manufacturing Engineer with expertise in medical device manufacturing. This role involves developing and optimizing cost-effective manufacturing processes, collaborating with contract manufacturers, and ensuring compliance with industry standards. You will work closely with cross-functional teams to drive new product development and validation processes. This is a fantastic opportunity to contribute to innovative medical solutions while working in a dynamic and supportive environment. If you're passionate about engineering and eager to make a difference, this role is perfect for you!

Qualifications

5+ years experience in medical device manufacturing engineering.
Proficient in SolidWorks for modeling and drawing.
Experience with contract manufacturers for capital equipment.

Responsibilities

Develop and optimize manufacturing processes for medical devices.
Create production-level assembly and part drawings.
Collaborate with cross-functional teams on product development.

Skills

Medical Device Manufacturing

Design for Manufacturing (DFM)

SolidWorks

Process Validation

New Product Development

Statistical Analysis Software

Vendor Management

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Minitab

JMP

Job description

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

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