TE Connectivity
Senior Manufacturing & Process Development Engineer
TE Connectivity, Minneapolis, Minnesota, United States, 55447
Senior Manufacturing & Process Development Engineer
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Job Overview TE Connectivity's R&D and Process Development Engineering Teams significantly drive New Product Development (NPD) initiatives through product/process development projects within existing manufacturing technologies and methods while striving to implement new manufacturing technologies that provide improved process capabilities. This role is a critical element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this transition. They support Product Development in the optimization of designs for manufacturability, including process and test method validation, as well as design, development, and qualification of tooling/equipment. You will create, develop, and document all manufacturing processes, support supply chain to verify supplier compliance and capability, and initiate and implement programs to continuously improve quality, cost, and cycle time while adhering to all appropriate specifications, regulatory requirements, and customer requirements.
What You Will Be Doing Help develop processes to manufacture products that enable groundbreaking medical therapies. At TE Connectivity, you will find a culture that rewards hands‑on engineering spirit and innovation.
Key Responsibilities
Hands‑on experience with complex steerable or multi‑lumen catheter assembly development and manufacturing, including manufacturing technologies with mandrel design, PTFE assembly, reflow, braiding, tipping, and extrusion.
Demonstrated experience in Medical Device New Product Development, including process development, equipment/fixture design and qualification, and test method and process validations.
Thorough understanding of Quality Management Systems (QMS) requirements that involve:
Process Mapping
Manufacturing Process Instructions
DOE and Process Characterization
OQ/PQ Protocol and Reports
IQ/OQ Protocols and Reports
PFMEAs
MVP/MVRs
Proven track record of product transfers from new product development to operations or across sites, including coaching and mentoring during the transfer.
Managing activities with risk to project timelines, developing contingency plans, and outlining deliverables and milestones.
Effective communication: preparing status reports, modifying schedules, and managing project plans; keeping stakeholders, customers, and others informed of project status and related issues.
Demonstrated experience working with cross‑functional teams while being self‑driven.
Develop bills of materials and assembly methods documentation while providing any necessary training to technicians and assemblers.
Using problem‑solving and DMAIC tools to improve processes.
Observing safety and security procedures; reporting potentially unsafe conditions; using equipment and materials properly.
Experience with design requirements such as Bioburden or Particulates.
Required Background
Bachelor's degree in Engineering, Plastics, Chemical, Biomedical, or Mechanical Engineering (preferred).
5+ years of experience in the Medical Device Industry, with the majority of time in new process development or transfers.
Experience with design controls, FDA regulation, GMP practices, and QSR requirements.
CAD proficiency—SolidWorks and Mastercam.
MS Office proficiency.
Ability to achieve goals through effective planning and prioritization to meet immediate and long‑range needs.
Well‑organized, detail‑oriented, with excellent oral and written communication skills.
Competencies SET : Strategy, Execution, Talent (for managers)
Compensation
Competitive base salary commensurate with experience: $102,700 - $154,000 (subject to change based on physical location).
Posted salary ranges are made in good faith; TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
Total Compensation = Base Salary + Incentive(s) + Benefits.
Benefits
A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off, and voluntary benefits.
EOE EOE, Including Disability/Vets.
Recruitment Fraud Notice TE Connectivity has become aware of fraudulent recruitment activities being conducted by individuals or organizations falsely claiming to represent TE Connectivity. Please be advised that TE Connectivity never requests payment or fees from job applicants at any stage of the recruitment process. All legitimate job openings are posted exclusively on our official careers website at te.com/careers, and all email communications from our recruitment team will come only from actual email addresses ending in @te.com. If you receive any suspicious communications, we strongly advise you not to engage or provide any personal information, and to report the incident to your local authorities.
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Job Overview TE Connectivity's R&D and Process Development Engineering Teams significantly drive New Product Development (NPD) initiatives through product/process development projects within existing manufacturing technologies and methods while striving to implement new manufacturing technologies that provide improved process capabilities. This role is a critical element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this transition. They support Product Development in the optimization of designs for manufacturability, including process and test method validation, as well as design, development, and qualification of tooling/equipment. You will create, develop, and document all manufacturing processes, support supply chain to verify supplier compliance and capability, and initiate and implement programs to continuously improve quality, cost, and cycle time while adhering to all appropriate specifications, regulatory requirements, and customer requirements.
What You Will Be Doing Help develop processes to manufacture products that enable groundbreaking medical therapies. At TE Connectivity, you will find a culture that rewards hands‑on engineering spirit and innovation.
Key Responsibilities
Hands‑on experience with complex steerable or multi‑lumen catheter assembly development and manufacturing, including manufacturing technologies with mandrel design, PTFE assembly, reflow, braiding, tipping, and extrusion.
Demonstrated experience in Medical Device New Product Development, including process development, equipment/fixture design and qualification, and test method and process validations.
Thorough understanding of Quality Management Systems (QMS) requirements that involve:
Process Mapping
Manufacturing Process Instructions
DOE and Process Characterization
OQ/PQ Protocol and Reports
IQ/OQ Protocols and Reports
PFMEAs
MVP/MVRs
Proven track record of product transfers from new product development to operations or across sites, including coaching and mentoring during the transfer.
Managing activities with risk to project timelines, developing contingency plans, and outlining deliverables and milestones.
Effective communication: preparing status reports, modifying schedules, and managing project plans; keeping stakeholders, customers, and others informed of project status and related issues.
Demonstrated experience working with cross‑functional teams while being self‑driven.
Develop bills of materials and assembly methods documentation while providing any necessary training to technicians and assemblers.
Using problem‑solving and DMAIC tools to improve processes.
Observing safety and security procedures; reporting potentially unsafe conditions; using equipment and materials properly.
Experience with design requirements such as Bioburden or Particulates.
Required Background
Bachelor's degree in Engineering, Plastics, Chemical, Biomedical, or Mechanical Engineering (preferred).
5+ years of experience in the Medical Device Industry, with the majority of time in new process development or transfers.
Experience with design controls, FDA regulation, GMP practices, and QSR requirements.
CAD proficiency—SolidWorks and Mastercam.
MS Office proficiency.
Ability to achieve goals through effective planning and prioritization to meet immediate and long‑range needs.
Well‑organized, detail‑oriented, with excellent oral and written communication skills.
Competencies SET : Strategy, Execution, Talent (for managers)
Compensation
Competitive base salary commensurate with experience: $102,700 - $154,000 (subject to change based on physical location).
Posted salary ranges are made in good faith; TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
Total Compensation = Base Salary + Incentive(s) + Benefits.
Benefits
A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off, and voluntary benefits.
EOE EOE, Including Disability/Vets.
Recruitment Fraud Notice TE Connectivity has become aware of fraudulent recruitment activities being conducted by individuals or organizations falsely claiming to represent TE Connectivity. Please be advised that TE Connectivity never requests payment or fees from job applicants at any stage of the recruitment process. All legitimate job openings are posted exclusively on our official careers website at te.com/careers, and all email communications from our recruitment team will come only from actual email addresses ending in @te.com. If you receive any suspicious communications, we strongly advise you not to engage or provide any personal information, and to report the incident to your local authorities.
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