Work180
Senior Manufacturing & Process Development Engineer
Work180, Minneapolis, Minnesota, United States, 55447
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 and striving to implement new manufacturing technologies to 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 of manufacturability. This responsibility also includes process and test method validation along with design, develop, and qualify tooling/equipment. Create, develop and document all processes in the manufacturing process. Supports supply chain to verify supplier compliance and capability, initiate and implement programs to continuously improve quality, cost and cycle time and adhere to all appropriate specifications, regulatory requirements, and customer requirements.
What you will be doing Do you want to work with cutting edge technology? Help develop processes to manufacture products that enable groundbreaking medical therapies. At TE Connectivity, you will find a culture that rewards hands-on engineering. This is a great opportunity to join our team that is seeking a like-minded person with the drive and focus on innovation.
As part of TE's Medical New Product Development Engineering team at our Plymouth, MN site, strong candidates will need experience in the following areas:
Hands-on experience with complex steerable or multi-lumen catheter assembly development and manufacturing with manufacturing technologies including mandrel design, PTFE assembly, reflow, braiding, tipping and extrusion
Demonstrated experience in Medical Device New Product Development including process development along with 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 product transfers from site to site, including the ability to coach and mentor others during the transfer
Managing activities with risk to project timelines, developing contingency plans, while outlining deliverables and milestones
An effective communicator that prepares status reports, modifies schedules, and manages project plans. Keeps stakeholders, customers, and others informed of project status and related issues
Demonstrated experience with working with cross-functional teams while being self-driven
Develop bills of materials and assembly methods documentation while providing any training needed to technicians and assemblers
Using problem solving and DMAIC tools to solve processes and process improvements
Observe safety and security procedures; reporting potentially unsafe conditions; using equipment and materials properly
Experience with design requirements like Bioburden or Particulates
What your background should look like
Bachelor's degree in Engineering, Plastics, Chemical, Biomedical or Mechanical Engineering preferred
5+ years’ experience working 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 with effective planning and prioritization skills to meet immediate and long-range needs
Must be well-organized, detail-oriented, with excellent oral and written communication skills
Competencies
SET: Strategy, Execution, Talent (for managers)
About TE Connectivity TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at te.com/careers, and on LinkedIn, Facebook, WeChat, Instagram and X.
Compensation
Competitive base salary commensurate with experience: $102,700 - $154,000 (subject to change dependent on location)
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, Including Disability/Vets
Important Notice Regarding Recruitment Fraud
TE Connectivity has become aware of fraudulent recruitment activities. TE never requests payment or fees from job applicants. All legitimate openings are posted on our official careers site. If you receive suspicious communications, do not engage and report the incident to your local authorities.
#J-18808-Ljbffr
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 and striving to implement new manufacturing technologies to 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 of manufacturability. This responsibility also includes process and test method validation along with design, develop, and qualify tooling/equipment. Create, develop and document all processes in the manufacturing process. Supports supply chain to verify supplier compliance and capability, initiate and implement programs to continuously improve quality, cost and cycle time and adhere to all appropriate specifications, regulatory requirements, and customer requirements.
What you will be doing Do you want to work with cutting edge technology? Help develop processes to manufacture products that enable groundbreaking medical therapies. At TE Connectivity, you will find a culture that rewards hands-on engineering. This is a great opportunity to join our team that is seeking a like-minded person with the drive and focus on innovation.
As part of TE's Medical New Product Development Engineering team at our Plymouth, MN site, strong candidates will need experience in the following areas:
Hands-on experience with complex steerable or multi-lumen catheter assembly development and manufacturing with manufacturing technologies including mandrel design, PTFE assembly, reflow, braiding, tipping and extrusion
Demonstrated experience in Medical Device New Product Development including process development along with 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 product transfers from site to site, including the ability to coach and mentor others during the transfer
Managing activities with risk to project timelines, developing contingency plans, while outlining deliverables and milestones
An effective communicator that prepares status reports, modifies schedules, and manages project plans. Keeps stakeholders, customers, and others informed of project status and related issues
Demonstrated experience with working with cross-functional teams while being self-driven
Develop bills of materials and assembly methods documentation while providing any training needed to technicians and assemblers
Using problem solving and DMAIC tools to solve processes and process improvements
Observe safety and security procedures; reporting potentially unsafe conditions; using equipment and materials properly
Experience with design requirements like Bioburden or Particulates
What your background should look like
Bachelor's degree in Engineering, Plastics, Chemical, Biomedical or Mechanical Engineering preferred
5+ years’ experience working 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 with effective planning and prioritization skills to meet immediate and long-range needs
Must be well-organized, detail-oriented, with excellent oral and written communication skills
Competencies
SET: Strategy, Execution, Talent (for managers)
About TE Connectivity TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at te.com/careers, and on LinkedIn, Facebook, WeChat, Instagram and X.
Compensation
Competitive base salary commensurate with experience: $102,700 - $154,000 (subject to change dependent on location)
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, Including Disability/Vets
Important Notice Regarding Recruitment Fraud
TE Connectivity has become aware of fraudulent recruitment activities. TE never requests payment or fees from job applicants. All legitimate openings are posted on our official careers site. If you receive suspicious communications, do not engage and report the incident to your local authorities.
#J-18808-Ljbffr