Senior Manufacturing Engineer

19 hours ago

Cambridge, Massachusetts, United States PostJobMatches By WorkStaff USA Staffing Agency LLC Full time

PostJobMatches By WorkStaff USA Staffing Agency LLC is a leading staffing agency in the job placement industry providing top-notch professionals to facilities across the country. Our team of experienced recruiters work together to match the best candidates with the right job and/or business opportunities.

We are seeking a Senior Manufacturing Engineer to join our team in Cambridge, MA. The ideal candidate will have a strong background in medical device manufacturing engineering, with experience in new product development, design transfer to production, and process validation.

The Senior Manufacturing Engineer will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices. This includes embly lot release testing, sterilization, and packaging. The candidate will also be responsible for producing production-level embly and part drawings for all components and sub-embly.

The ideal candidate will have a strong understanding of Design for Manufacturing (DFM), Six Sigma, and LEAN principles, and will be able to incorporate these principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency.

The Senior Manufacturing Engineer will also be responsible for leading and collaborating with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites, while fostering strong partnerships.

The candidate will have a strong technical background in mechanical engineering, with experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing. Proven track record in design transfer process validation and knowledge of sterilizable polymers and catheter fabrication techniques is also required.

The ideal candidate will be highly proficient in SolidWorks, with experience in tool and fixture design, and will have a strong understanding of statistical analysis software like Minitab or JMP for process monitoring and improvement.

We offer a competitive pay rate of $65 per hour, with a total position of 1. The candidate will work 35 hours per week, with 7 hours per day. Relocation is not required, and visa sponsorship is not eligible.

Key Responsibilities:

Develop and optimize efficient, cost-effective, and validated manufacturing processes for medical devices

Produce production-level embly and part drawings for all components and sub-embly

Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs

Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites

Act as a liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities

Review engineering product specifications and CAD data/drawings as part of the design review process

Responsible for part/drawing release and the accuracy of the Bill of Materials (BOM)

Drive the development and of complex experiments and tests on new or existing product lines to qualify and validate manufacturing processes

Responsible for Characterization and Validation activities, including CTQ flowdown and identification of critical control points within manufacturing

Deploy manufacturing risk essment and mitigations, including handson and resourceful action plans

Developing and maintaining manufacturing work instructions, equipment instructions, and other doents 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 (Deliver):

Development and maintenance of project task list for DFM Activities

Create and maintain uptodate BOMs, work instructions, and travelers

Creation and maintenance of pFMEA

Qualifications:

Education: Bachelors 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 ss using SolidWorks, including proficiency with embly 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

Remote Work:

No

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