Senior Product Development Engineer

Date: Feb 18, 2021

Location: Fridley – Minnesota, US, 55421

Company: Heraeus

Senior Product Development Engineer
Location Fridley – Minnesota
Full Time

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of approximately 14,900 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.



The primary responsibility of this position is to design and develop medical products from concept through process validation. This individual will engage in product and process development for a variety of parts from components, to complex assemblies, to finished devices/systems. This position will work in a dynamic, innovative and collaborative environment including hands-on and customer-interfacing interactions.



  • Lead or contribute to design, development, validation activities through product life cycle for neuromodulation products in accordance to project scope
  • Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions.
  • Execute deliverables for Design Control process to deliver the desired product to production in a cost-effective manner while hitting product performance and profitability goals
  • Complete and manage Design History File(s), Design Control, Process Validation and all necessary activities in accordance to all internal and external processes, procedures and standards (MDR, ISO, EN, etc).
  • Read and understand customer specification/requirements to translate into clear, concise performance and functional requirement.
  • Develop strategy for robust design, process and testing criteria to satisfy requirements.
  • Conduct engineering evaluation, characterization, design of experiments (DOE), bench testing or other verification activities to improve and confirm capability in the design and process.
  • Assess, anticipate and mitigate risks through risk assessment tools such as FMEA, root cause analysis, and etc throughout the product development lifecycle.
  • Ensure that proper technology processes are developed, implemented maintained, and documented to successfully introduce new products into manufacturing. Involved in prototyping, process development, confirmation runs, and validation. Available to support and trouble shoot production issues as needed.
  • Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality and controls, and process costs.
  • Work with development technicians/operators to perform hands on prototyping or testing.
  • Provide directions and instructions to development/production operators and technicians on new and revised processes.
  • Assist in new equipment identification, procurement, installation qualification, document creation, and training. May participate in execution of these activities as needed.
  • Coordinate new tooling/fixturing identification, procurement, and verification. May participate in execution of these activities as needed.
  • Demonstrate and utilize tried and true engineering methods and resources to streamline the development process.  Evaluate new technologies and ideas for new products.
  • Use statistical tools to analyze data, make development decisions, and improve process capability (Six Sigma, SPC, DOE)
  • Develop test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
  • Manage workflow and responsibilities with cross-functional teams to establish, implement and deliver products to production that meet project timeline, design, and profitability targets
  • Strong understanding of leads design and manufacturing (acceptable tolerances, design considerations, cycle times, scrap rates, etc.)
  • Other duties may be assigned as required.


Minimum qualifications:

  • Bachelor’s Degree in Engineering or related technical field required.
  • A minimum of 8 years of engineering experience with a minimum of 4 years in medical device products (neuromodulation experience and project/people management experience are a plus)
  • Proven experience in 3D modeling (Solidworks preferred) and working knowledge of drafting specifications such as GD&T
  • Experience in a regulated environment and demonstrated competence in required documentation and industry accepted practices such as Good Manufacturing Practices (GMP), ISO 13485 Design Control, and Quality Systems Regulation (QSR)
  • Knowledge and effective application of engineering tools (Risk Analysis, FMEA, DOE, Process Validation, protocol/report documentation) required
  • Familiarity with Process Instrumentation and Controls, development and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies.
  • Excellent technical writing skills

Nearest Major Market: Minneapolis