OPPORTUNITIES

Senior Process Development Engineer

The Sr. Process Development Engineer is responsible for providing leadership and insight into the development of new manufacturing processes as part of our product development program. As our Senior Process Development Engineer for our early-stage company, you will be responsible for originating and ensuring that manufacturing processes are developed, implemented and validated throughout the process development cycle. You will also be responsible for planning, coordinating and managing all manufacturing activities to ensure that new product designs are transferred successfully from development to production.

 

Primary Responsibilities

  • Interfacing regularly with product development teams by developing manufacturing processes including tool development, process flow and outputs, manufacturing process instructions and production documentation.
  • Aiding product development teams with the development of essential production and process control deliverables including: equipment qualification and control, process failure mode and effects analysis (PFMEA), process verification and validation, manufacturing documentation (DHR/DMR) and final product release.
  • Participating in the product development team meetings and design reviews with a focus on manufacturability: Assisting in authoring operations plans, product build plans, test protocols and final reports.
  • Understanding and applying engineering tools including: FMEA, IQ/OQ/PQ, Gage R&R, statistical techniques (Cpk, SPC), design of experiments (DOE) and problem solving (i.e. DMAIC).
  • Assisting contract manufacturers and suppliers with process development activities by providing qualified tools, equipment and processes to ensure consistent product quality. You will work with suppliers to resolve conflicts and recommends revisions as necessary.
  • Working closely with the Supply Chain Manager to manage inventory, coordinating new tooling and equipment, and managing non-conforming product.
  • Supporting the Quality System in respect to production and process controls. Developing Standard Operating Procedures (SOPs), implementing and training others for product specific Work Instructions (WIs), and creating in-process control systems.
  • Establishing policies and procedures for Equipment Control and taking responsibility for the in-house Preventive Maintenance and Calibration programs.
  • May involve up to 25% travel time to work with contract manufacturers.

 

Qualifications

  • Bachelor’s degree in an engineering discipline is required, mechanical engineering emphasis strongly preferred.
  • A quality engineering certification, such as CQE is optimal.
  • 8+ years working in a medical device company as an Engineer required.  Previous experience with Class III implantables preferred, quality engineering focus optimal.
  • Experience with new product development and product realization required.
  • Strong knowledge of statistical techniques and quality/reliability tools (FMEA, FTA, ANOVA, DOE, SPC, Gage R&R, etc).
  • Strong knowledge of external standards, including 21CFR820, ISO 13485, ISO 14971.
  • Experience with various manufacturing processes such as crimping, welding, bonding and associated fixtures required.
  • Experience with EN45502 preferred.
  • Experience with mechanical and electrical CAD software (SolidWorks, OrCad, PADS) necessary.
  • Experience with electronic document control systems optimal.
  • Start up or small company experience a plus.

 

The Intangibles

  • Demonstrates a sophisticated level of engineering understanding.
  • Ease with developing strong working relationships to ensure superior customer service and solutions.
  • Superior project management and organizational skills, proven record of consistently following through on commitments.
  • Organized with strong analytical and problem solving skills.
  • Strong, effective presentation and interpersonal skills required.
  • Team focused, self-motivating and passionate for innovation and quality.
  • Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all interactions both inside and outside the Company.

 

Please send your cover letter and resume via email to: , with jobcode 474523 in the subject line. This position is eligible for relocation assistance.

NeuroVista is proud to be an equal opportunity employer.

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