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Sr. / Pr. Process Development Engineer (PR/4001459) Maple Grove, Minnesota

Salary: USD130000 - USD160000 per annum + Bonus, PTO, Equity

Position Description:

The Senior / Principal Process Development Engineer is responsible for delivering high quality medical products to our customers by driving critical projects from concept through commercialization. The Process Development Engineer will develop, qualify, and validate new equipment and fixtures for use in manufacturing. This position will be responsible to support the Operations team in implementing new processes for our disposable, reusable, and capital products. In particular, the majority of the position will focus on processes and equipment for the disposable product.

Success in this position relies heavily on the development and validation of the new and existing manufacturing processes. Due to the fast-paced nature of the work environment, success in this role requires the candidate to be in the office most days.

This role will report directly to the Director of Mechanical Engineering and work on projects with cross-functional impact and visibility.

Principal Responsibilities:

• Collaborate with key stakeholders to define the requirements for new and existing capital equipment purchases to support critical business objectives
• Plan and complete multi-factor design of experiments (DOE) using statistical software
• Work in partnership with the Operations team to develop and improve new and existing processes
• Complete equipment qualifications (IQ, OQ)
• Create high-level and detailed process flow charts for equipment / fixtures
• Support the Operations team in the development of work instructions and pFMEA documentation
• Manage automation vendors for generating equipment requirements, testing plans, and capital equipment installations (FAT, SAT)
• Design, develop, document, and qualify numerous fixtures and equipment using SolidWorks
• Facilitate the use of 3D printers and outside machine shops to fabricate equipment and fixtures
• Write complex technical reports based on laboratory experimentation
• Work cooperatively with quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all job responsibilities and duties.

Required Education, Experience, and Qualifications:

• S degree in Mechanical Engineering or Biomedical Engineering from ABET accredited school
• 5+ years of process development or product development experience
• Medical device experience (majority of experience)
• Developing processes (improving legacy processes and developing new processes)
• Proficient with creating flow charts (e.g., process, swim lane, fishbone, fault tree, etc.)
• Ability to efficiently complete process development documentation (Protocols/Reports, IQ, OQ, PQ, PPQ, SV)
• SolidWorks experience with designing, building, documenting, and qualifying fixtures and machines for production use
• Good lab skills (keeps lab notebook, soldering, assembly, light machine shop work, 3D printing, etc.)
• Good documentation skills (willing to complete multiple DCR’s per week)
• Superior technical writing and communication skills
• Quick learner and can work well in cross-functional team setting

Required or Highly Desired Abilities and Attributes:

• Works cross-functionally (Quality, Regulatory, Operations, Clinical, Marketing)
• Strong electrical aptitude
• Knowledge of industrial programming languages (Ladder Logic, Python, C++, R)
• Data-driven, knowledge of advanced statistical concepts (e.g., GR&R, DOE, ANOVA, etc.)
• Experience with design for manufacturing (DFM) and design for assembly (DFA)
• Certified six sigma black belt or lean certification

Working Conditions:

• Light work, exerting up to 20 lbs. of force or less
• Significant work pace and pressure due to deadlines
• Stand or sit for 8 hours per day