R&D Engineer

3 weeks ago

Sandy, United States MILLENNIUMSOFT Full time
Job Title: R&D Engineer

We are seeking a highly skilled R&D Engineer to join our team at MillenniumSoft. As a key member of our product development team, you will be responsible for designing and developing innovative products that meet the needs of our customers.

Key Responsibilities:
  • Design and develop product systems, subsystems, and components using design for manufacture principles and geometric dimensioning and tolerancing tools.
  • Integrate product systems and subsystems to meet business objectives by addressing customer needs and product requirements under defined cost targets.
  • Identify the best tools and approaches to effectively solve engineering problems to develop/optimize designs by leveraging appropriate mix of first principles/analytical, computational, and experimental methods.
  • Ensure implementation and rigor of product development processes and design control procedures.
  • Support evaluation and assessment of new technologies, intellectual property, products, processes, and industry trends that can or have the potential to impact our business strategies.
  • Support current products in terms of quality, manufacturing, supply continuity, and cost improvement.
  • Support execution of technical and/or cross-functional project work.
  • Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance.
  • Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.
  • Translate customer needs into engineering requirements into specific product, packaging, and process specifications.
  • Analyze design solutions using engineering first principles and advanced engineering methods such as FEA.
  • Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.
  • Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis.
  • Develop realistic and actionable design plans.
Requirements:
  • BS degree in Engineering (Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering, or a closely related engineering degree required).
  • A Master's degree in engineering is preferred.
  • Minimum of 3 years of engineering experience or equivalent is required with a strong preference for at least 2 years of product development and design experience in medical devices/products.
  • Medical device design and development experience related to high-volume manufacturing is strongly preferred.
  • Strong interpersonal and influencing skills.
  • Advanced technical judgment.
  • Strong communication skills.
  • Team-oriented.
  • Strong understanding of disciplined product development processes, regulatory, and quality requirements.
  • Strong fit with MillenniumSoft values.
Preferred Qualifications:
  • Demonstrated ability to deliver robust products by following a disciplined design process such as Design for Six Sigma.
  • Demonstrated ability to utilize statistical tools, computer analysis, and engineering fundamentals to support sound engineering judgment. Solidworks, Minitab, and FEA (Abaqus/Fluent) experience is preferred.
  • Experience in developing project plans.
  • Strong design control experience.
  • Experience writing invention disclosures, patent applications, patents, and publications.
  • Developed understanding of DOE and statistical methods.
  • Understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions.
  • Experience with clinical studies, human physiology, and simulated product use studies.
  • Experience with contact and non-contact metrology.
  • Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping, and automated assembly techniques, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting.
  • Experience with manufacturing process validation including strategy development, First Article Inspection, Factory Acceptance Testing, and IQ/OQ/PQ's.
  • Knowledge of disciplined product development processes, regulatory, and quality requirements such as 21CFR820.30.

We are looking for a candidate with a strong background in engineering and product development, with a passion for innovation and a commitment to delivering high-quality products. If you are a motivated and talented engineer looking for a new challenge, we encourage you to apply for this exciting opportunity.

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