Senior Process Development Engineer

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The Senior Process Development Engineer is responsible for technical leadership and timely development and evaluation of new manufacturing processes to support the needs of the customer. This requires representation for the department in inter-company relations and providing technical expertise to internal clients and the customer. Senior Engineers may have direct reports and/or operate in a Lead Engineer capacity, managing resources and/or small to mid-sized projects.

• Process Concept
  • Proposes new process/equipment/core technology improvement concepts.
  • Understands how user and patient needs translate to process and functional product outputs.
  • Aids in selection of process improvements to increase UPH, yield, and manufacturability on pre-production and/or production products.
  • Participates in strategic planning and department goal setting
  • Leads phase II and process related quoting activities to support new project costing.
  • Provides guidance on process standards, templates, and best practices.
• Process Design & Development
  • Translates customer requirements into process specific outputs.
  • Plans and manages the development and evaluation of process assembly steps.
  • Plans, manages, and conducts activities surrounding risk assessment (e.g., FMEA) of product concepts.
  • Participates in risk assessment (e.g., DFMEA) or product concepts and translates customer DFMEA requirements to pFMEA and team.
  • Manages process capability, DOE, and other characterization studies to analyze and report on results using statistical analysis.
  • Completes engineering documentation (e.g., manufacturing and inspection procedures (MIPs), router/BOM updates, etc.) to prepare and finalize documentation before verification and validation testing.
  • Participates in project planning, business case evaluation, and project tracking.
  • Leads customer meetings related to process specifics and process details.
• Verification & Validation
  • Manages determination of qualification requirements and criteria for new products/processes based on Intricon and customer procedures/requirements.
  • Leads timeline planning and operations resource requests for execution of qualification activities.
  • Prepares and releases verification/validation protocols and reports (IQ, OQ, PQ, etc.)
  • Leads and manages the development of master validation plan (MVP) documentation.
  • Collaborates with other functions to execute project deliverables.
  • Develops standard documentation methodologies.
  • Communicates directly with customer to define validation strategy, approach, and constraints.
• Work Conditions
  • Use manual and light power tools to make and test prototypes.
  • Works in a development lab environment in addition to office.
  • May be in and around a tool shop.
  • May be in a cleanroom or controlled environment area.
  • May travel to customer or vendors for project driven objectives.
• Working Through Others/Interpersonal Relationships
  • Establishes extensive interdepartmental and interdivisional networks.
  • Has an in-depth understanding of the various organizational interfaces (laboratory, engineering, sales, and marketing)
  • Implements comprehensive educational plans to develop, maintain, and expand state-of-the-art knowledge in functional area.
  • Participates in recruiting and staffing.

• Accountability
• Analytical
• Attention to Detail
• Communication
• Cultivate Customer Relationship
• Continuous Attention to Process Improvement
• Embrace Differences
• Innovation
• Problem Solving/Critical Thinking
• Teamwork

• Bachelor’s degree in mechanical, chemical, bio-medical engineering or similar field of study or equivalent experience

• Minimum six (6) years engineer experience in medical device industry or equivalent.
• Extensive expertise in one or several fields of the technology.

• Experience in design controls and Quality System Regulations.
• Extensive verbal and…