BD

Associate Staff Engineer, Product Development

BD

full-time

Posted on:

Location Type: Hybrid

Location: Sandy • Utah • 🇺🇸 United States

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Job Level

JuniorMid-Level

About the role

  • Lead cross-functional value engineering initiatives to identify and implement cost-saving opportunities without compromising product quality or performance.
  • Represent the R&D function while collaborating with Quality, Regulatory, and Manufacturing teams to ensure concepts meet the Design Input’s defined for the product.
  • Analyze product designs and specifications to identify opportunities for simplification, standardization, and material optimization.
  • Develop and maintain design control documentation including design history files (DHF), risk management files, and verification/validation protocols.
  • Drive design reviews and facilitate root cause analysis for design-related issues.
  • Support regulatory submissions by ensuring design documentation meets FDA, ISO 13485, and other applicable standards.
  • Mentor junior engineers and provide technical leadership in value engineering and design control best practices.
  • Utilize tools such as DFMEA, PFMEA, CAD, and PLM systems to support engineering decisions.
  • Stay current with industry trends, materials, and technologies to continuously improve product design and cost efficiency.

Requirements

  • Bachelor's or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
  • 8 years of experience in product development, value engineering, and design control within a regulated industry (medical devices preferred).
  • Deep understanding of design control requirements under FDA 21 CFR Part 820 and ISO 13485.
  • Proven track record of leading successful value engineering projects with measurable cost savings.
  • Strong analytical and problem-solving skills with proficiency in engineering tools and software.
  • Excellent communication and leadership skills with the ability to influence cross-functional teams.
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work arrangements
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
value engineeringproduct developmentdesign controlrisk managementroot cause analysisdesign simplificationmaterial optimizationanalytical skillsproblem-solving
Soft skills
communicationleadershipmentoringcollaborationinfluencing
Certifications
Bachelor's degreeMaster’s degreeISO 13485 certificationFDA compliance knowledge
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