Sr. NPI Process Development Engineer

Job Overview

The Senior NPI (New Product Introduction) and Process Development Engineer leads initiatives to mature medical device products from prototype to market through establishing and scaling of assembly 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 and leads process development engineers in successful execution.  The staff NPI engineer develops a strong client relationship, mentors colleagues, and is accountable for delivering to target COGS.

 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 but not limited to: fixture design, Mold design, injection molding, bonding technologies, reagent integration, QC methods, packaging, etc.
• Capable to develop, implement, and qualify potentially complex or advanced assembly processes with a high level of expertise and confidence of DFM
• Brings expertise on multiple technologies (e.g. laser welding, ultrasonic welding, heat staking, blisters, robotics, vision systems, etc.) to inform optimal process development strategies
• Capable to resource, delegate, constructively critique, educate, and monitor technical work to satisfy project deliverables
• Strong cross-functional global collaboration between Project Managers, New Product Development, Quality, Business development, and Manufacturing
• Strong external (client facing) communication and presentation skills, where process development objectives and manufacturing strategy are justified through a data driven and risk-based approach
• Capable of identifying risks to meet targeted COGS, and champions solutions to recover
• Generate project work proposals, including evaluation of COGs, Timeline, Capex, NRE, and NRT estimates reflective of stage gate requirements and data collection activities to give confidence to process reliability at high volume
• Initiate/manage capital equipment projects, including URS, FAT, and SAT activities, and working with strategic automation suppliers to customize equipment as needed. 
• Generate and/or approve documentation to support DHF and DMR
• Utilize 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 site(s) to proactively plan for and support product transfer
• Leverage lean methodologies (Kaizen, 3P, DMAIC, etc.), business acumen, and critical thinking to effectively scale and process improve workflows
• May supervise direct reports
• Travel as needed (domestic and international)
• Perform other duties as assigned
   

What your background should look like:

Education

• Bachelor's degree in engineering, Manufacturing, or equivalent preferred

Experience

• 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

Skills

• Expert in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization 
• Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings 
• Demonstrated expertise related to mechanical design of mfg. equipment, fixturing, and tooling  
• Strong understanding of manufacturing transfer 
• Strong problem solving, financial acumen, and business acumen 
• Excellent communication skills with the ability to speak effectively before groups of Team Members and External clients.  
• Thrives in a dynamic work environment with a broad spectrum of projects, technologies, and evolving priorities 
• Strong leadership skills with the ability to influence cross-functional teams

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Competencies