Senior Manufacturing & Process Development Engineer

Job Overview

TE Connectivity's R&D and Process Development Engineering Teams significantly drives 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 critical 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 such hands-on engineering spirit. 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 the 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 that includes manufacturing technologies with mandrel design, PTFE assembly, reflow, braiding, tipping and extrusion
• Demonstrated experience in Medical Device New Product Development which includes 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.  This also includes demonstrating the ability coach and mentor other during the process of the transfer.
• Managing activities with risk to the 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/or 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 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 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