R&D Engineer
MillenniumSoft Inc · Sandy, UT · 3 wk ago
Engineering$20–$30/hrFull-time
Location: Sandy, UT • Contract Term: 12+ Months • Hours: 40 hrs/week (Mon–Fri, 8 AM–5 PM)
About the Role
We are seeking an R&D Engineer with experience completing highly technical design analysis (first-principles design calculations, stress analysis, FEA, design of experiments, etc.). The ideal candidate will have strong technical design skills, excellent written and oral communication, and leadership abilities. This role requires a strong capability to interpret and ensure compliance with all local, state, federal, and BD safety regulations, quality policies, best practices, and procedures.
Responsibilities
- Drive design and development of product systems, subsystems, and components by understanding design space with design options and trade-offs, managing critical parameters, and using design-for-manufacture principles as well as 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 and develop/optimize designs by leveraging an 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 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 and 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 specifying measurement equipment, test set-up, measurement systems analysis, and data analysis.
- Develop realistic and actionable design plans.
- Demonstrate strong accountability for successful completion of designated tasks and team deliverables.
- Develop deliverables schedules and ensure efficient and effective transition from research to development to high-volume manufacturing globally.
- Collaborate effectively with laboratory technicians and support staff.
- Ensure compliance with BD quality policies, procedures, and practices, as well as all local, state, federal, and BD safety regulations.
- Proactively develop, maintain, and share technical knowledge in specialized area(s), staying up-to-date on current trends and best practices.
- Actively mentor and motivate team members and junior associates while ensuring effective cross-functional communication and engagement.
- Develop and apply innovative approaches to capture, retain, and communicate technical and project knowledge (tacit and implicit).
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, with a strong preference for at least 2 years of product development and design experience in medical devices/products.
- Education requirement may substitute for years of work experience as follows: Master’s and 3 years of relevant work experience.
- Medical device design and development experience related to high-volume manufacturing is strongly preferred.
- Strong interpersonal and influencing skills, advanced technical judgment, and communication skills.
- Team-oriented with a strong understanding of disciplined product development processes, regulatory, and quality requirements.
- Strong fit with BD values.
Skills & Experience
- 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.
- Experience with SolidWorks, Minitab, and FEA (Abaqus/Fluent) preferred.
- Experience in developing project plans and 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 plastic injection molding, metal stamping, and automated assembly techniques (solvent bonding, adhesive bonding, ultrasonic welding, 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 21 CFR 820.30.
Pay
$20–$30/hour
Notes
- Preference for local candidates; onsite meetings preferred but open to remote (phone/Skype) if candidate is not local.
- No relocation assistance offered.
- Stability in work history preferred (no unexplained gaps or frequent job changes).
- Ready-to-resume (RTR) candidates should include their resume with submittals if on file.