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 The Manufacturing & Process Development Engineer leads initiatives to mature medical device products from prototype to market through scaling of manufacturing processes and influence on device design to ensure DFM. This role collaborates on a global cross-functional level with project stakeholders to define a competitive manufacturing strategy.
Responsibilities Drive generation, implementation, qualification and optimization of fabrication processes for the fabrication of complex polymer consumables from prototype through high volume manufacturing with expertise and confidence of DFM.
Generate and own product requirement documents, test plans, V&V reports, PFMEAs, and Engineering Change Orders.
Utilize statistical process control for product development, validation and manufacturing optimization.
Planning and implementation of measures to fill technical gaps/risks or failures within the organization.
Specify and implement new manufacturing equipment.
Maintain collaborative relationships with clients and ensure expected deliverables are met or exceeded within the agreed upon timelines and budget.
Ensure the technological and manufacturing strategy alignment between R&D, PD and Operations.
Strong cross-functional global collaboration between PMO, NPD, CR, Quality, BD, and OPS.
Assist EH&S as needed, and champion a Safety First process and team culture.
Collaborate with Manufacturing site(s) to proactively plan for and support product transfer.
Leverage lean methodologies, business acumen, and critical thinking to effectively scale and process improve workflows.
Obtain components, supplies, and equipment to support prototype assembly, and conduct preliminary OEM vendor assessment and selection.
Champion company vision and culture.
Perform other duties as assigned.
What your background should look like: Bachelor's Degree in Engineering, Manufacturing or equivalent.
5 or more years of industry experience in process development and manufacturing (Life Science or related industries preferred).
Worked within an ISO 13485 regulated cleanroom environment (preferred).
Advanced knowledge of general engineering tools (LEAN or 6-sigma) such as DoE, FMEA, QFD, etc.
Experience on scaling up fabrication processes from R&D to manufacturing.
Experience in some of the following processes preferred:
Photolithography for mold generation.
Electroplating for nickel shim generation.
DRIE on silicon.
Wet silicon and glass etching.
Sputtering.
Evaporation.
Soft-lithography.
Machining processes (CNC milling, micro-milling, drilling, laser welding, grinding…).
Metrology.
Injection molding.
Skills Strong team player.
Strong understanding of manufacturing transfer and process validation & scale-up.
Excellent experimental design, data analysis, problem-solving and decision-making skills.
Autonomy in owning a process and troubleshooting issues.
Proficiency in MS Office tools, and 2D/3D design.
LEAN and 6-Sigma culture knowledge.
Fluency in English and Spanish preferred.
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 www.te.com and on LinkedIn, Facebook, WeChat, Instagram and X (formerly Twitter).
WHAT TE CONNECTIVITY OFFERS: We are pleased to offer you an exciting total package that can also be flexibly adapted to changing life situations - the well-being of our employees is our top priority!
Competitive Salary Package
Performance-Based Bonus Plans
Health and Wellness Incentives
Employee Stock Purchase Program
Community Outreach Programs / Charity Events
Employee Resource Group
Across our global sites and business units, we put together packages of benefits that are either supported by TE itself or provided by external service providers. In principle, the benefits offered can vary from site to site.
Location: Guipuzcoa, SS, ES, 20500
State: SS
Country/Region: ES
Travel: Less than 10%
Requisition ID: 126012
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