Sr. R&D Product Engineer - Salt Lake City, UT

Seeking a Sr. R&D Product Engineer with experience as a lead R&D engineer on a medical device product development program with demonstrated proficiency in mechanical design, tolerance stack-up analysis, Design for Manufacturability (DFM), and specification development. The R&D Engineer will have design capability with small plastic and metal parts, demonstrated proficiency with GD&T and experience in product V&V testing, medical device new product development & rapid prototyping to work for a global medical technology company in Salt Lake City, UT.  U.S. citizen/green card holder required.

Responsibilities:  This is a high-level, hands-on R&D engineering position that leverages medical device development, quality & manufacturing experience in new product and process development. Responsible for both the technical aspects of product design and development as well as the translation of marketing requirements into product specifications. 

  • Provide R&D Engineering support on Product Engineering Teams.
  • Provide on-going support to manufacturing site(s) for commercially available products
  • Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
  • Maintains a professional working relationship with internal & external customer and support staff.
  • Participates and leads cross-functional teams.
  • Provides technical support on components, material methods, systems and equipment.
  • Develops physical and functional test requirements to assure specifications and regulations are met.
  • Participates in periodic product franchise reviews.
  • Participate during design transfer activities.
  • Writes and approves protocols, reports and data.
  • Manages testing outlined in protocols and test methods.
  • Manages/develops validation studies on equipment & processes.
  • Conduct complaints investigations.
  • Understands and follows company procedures and regulatory requirements.
  • Participates in and provides input to training on department & segment procedures, and policies
  • Provide support to the regulatory department in writing technical submissions.
  • Manages project planning, budgeting, scheduling and tracking.
  • Plans and coordinates engineering test builds.
  • Analyzes problems in design, process and test development. Recommend/implement solutions.
  • Prepares and presents oral and written project updates and technical discussions.
  • Develops and implements procedures/policy.

Requirements:

  • BSME or related technical degree
  • Experience as the lead R&D engineer on a medical device product development program
  • Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
  • Design capability with small plastic and metal parts
  • Demonstrated proficiency with Geometric Dimensioning and Tolerancing (GD & T)
  • Significant experience in product verification and validation testing, medical device new product development and rapid prototyping
  • Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, food/beverage)
  • Clinical trial and/or animal trial experience
  • Proficient in technical writing of protocols and reports
  • Proven capability in writing clear and detailed testing and product assembly procedures
  • Impeccable documentation skills and adherence to design control procedures and GLP
  • Demonstrated experience in application of lean manufacturing principles
  • Comfortable in a dynamic working environment with a high amount of change
  • Demonstrated ability in using statistical experimental design and analysis techniques (i.e. Taguchi Design of Experiments)
  • Familiarity with Pro-E and/or FEA software
  • Ability to make and present engineering decisions  
  • Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must.
  • Must be a highly motivated self-starter with the ability to achieve results with minimal direction.
  • Requires a high-energy individual with excellent teamwork, partnering and negotiation skills.
  • Must demonstrate good judgment in selecting methods and techniques for obtaining solutions.
  • U.S. citizen/green card holder required.