Manufacturing & Process Dev Engineer

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 mfg 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 champions a Safety First process and team culture. 
•    Collaborates 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.
•    Champions 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 following processes preferred:
o    Photolithography for mold generation.
o    Electroplating for nickel shim generation.
o    DRIE on silicon.
o    Wet silicon and glass etching.
o    Sputtering.
o    Evaporation.
o    Soft-lithography.
o    Machining processes (CNC milling, micro-milling, drilling, laser welding, grinding…).
o    Metrology.
o    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.

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Competencies