Senior NPI Process Development Engineer

3 weeks ago


Englewood, Colorado, United States TE Connectivity Full time

Job Overview

The Senior NPI (New Product Introduction) and Process Development Engineer plays a crucial role in maturing medical device products from prototype to market. This involves establishing and scaling assembly processes, influencing device design to ensure Design for Manufacturability (DFM), and collaborating with global cross-functional teams to define a competitive manufacturing strategy.

Responsibilities:

  • Leads process development execution, from small-scale prototype production through to high-volume commercial readiness.
  • Leverages experience in assembly tooling and technologies to support prototype production through high-volume manufacture, including fixture design, mold design, injection molding, bonding technologies, reagent integration, quality control methods, packaging, and more.
  • Develops, implements, and qualifies complex or advanced assembly processes with a high level of expertise and confidence in DFM.
  • Brings expertise on multiple technologies, such as laser welding, ultrasonic welding, heat staking, blisters, robotics, vision systems, and more, to inform optimal process development strategies.
  • Resources, delegates, critiques, educates, and monitors technical work to satisfy project deliverables.
  • Collaborates with Project Managers, New Product Development, Quality, Business Development, and Manufacturing teams.
  • Communicates effectively with external clients, justifying process development objectives and manufacturing strategies through data-driven and risk-based approaches.
  • Identifies risks to meet targeted COGS and champions solutions to recover.
  • Generates project work proposals, including COGS, timeline, Capex, NRE, and NRT estimates, reflective of stage gate requirements and data collection activities.
  • Initiates and manages capital equipment projects, including URS, FAT, and SAT activities, and works with strategic automation suppliers to customize equipment as needed.
  • Generates and/or approves documentation to support Design History File (DHF) and Device Master Record (DMR).
  • Utilizes statistical process control for product development and manufacturing optimization.
  • Assists EH&S as needed and champions a safety-first process and team culture.
  • Collaborates with Manufacturing sites to proactively plan for and support product transfer.
  • Leverages lean methodologies, business acumen, and critical thinking to effectively scale and process improve workflows.
  • May supervise direct reports.
  • Travels as needed (domestic and international).
  • Performs other duties as assigned.

Requirements:

  • Bachelor's degree in engineering, manufacturing, or equivalent preferred.
  • 5+ years of relevant engineering experience.
  • Blister/Reagent Integration Technology experience required.
  • Established, scaled, and improved production lines.
  • Worked within an ISO 13485 regulated environment.
  • SolidWorks experience preferred.
  • Smartsheets experience preferred.
  • Minitab experience preferred.

Competencies:

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork



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