Senior R&D Engineer

MillenniumSoft Inc; Salt Lake City (UT); On-site; USD 55,000 - 76,000; Full time

Job summary

MillenniumSoft Inc is seeking a Senior R&D Engineer in Salt Lake City for a 5+ month contract on W2. Role focuses on sustaining engineering for VAD portfolio with emphasis on ISO 13485, 14971, and cross-functional collaboration. 40 hours/week, first shift, pay rate $40–$55/hr.

Ideal candidate has a BS (Mechanical or Biomedical) and 4–6 years in medical device design, with experience in design controls and statistical methods.

Qualifications

• BS degree in engineering (Mechanical or Biomedical) required; Master’s preferred.
• 4–6 years of engineering experience; medical device design experience is strongly preferred.

Responsibilities

• Lead or support design and development activities for existing products.
• Develop test methods, verification plans, and data analysis.
• Collaborate with QA, Regulatory and Manufacturing to ensure design controls.
• Translate customer needs into product specifications and design improvements.
• Drive project schedules and ensure on-time completion per plan.

Skills

Design control leadership

Cross-functional collaboration

DOE

Statistical methods

Problem solving

Education

BS in Mechanical or Biomedical Engineering

Master's degree preferred

Tools

Solidworks

Minitab

FEA (Abaqus / Fluent)

Job description

Job Category: Engineering

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Job Description Summary

Client Medical - Vascular Access Devices - is searching for a Senior R&D Engineer to be part of a team focused on sustaining engineering activities to support the VAD portfolio optimization program.

Job Title - Senior R&D Engineer

Location - Salt Lake City, UT

Duration - 5+ Months

Total Hours/week - 40.00

pay rate-$40-55/hr

1st Shift

Client: Medical Device Company

Job Category: Engineering

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Description

Job Description Summary

Client Medical - Vascular Access Devices - is searching for a Senior R&D Engineer to be part of a team focused on sustaining engineering activities to support the VAD portfolio optimization program.

The scope of this position includes, working knowledge of Quality Management Systems (ISO 13485), design history files and risk management (ISO 14971). We are recruiting a highly driven senior engineering team leader with passion for problem solving and a proven track record of cross-function collaboration on a global scale.

This is a fixed-term position (through September 2022).

The successful candidate will be responsible for the following activities:

Product Design

• Lead or support design and development activities for existing products.
• Gap assessment and remediation supporting product regional registration .
• Participate in executing 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
• Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
• Develop design verification traceability matrices and associated requirements analysis
• Collaborate and lead in developing project schedules and drive technical success and on time completion per project schedule
• Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
• Ensure compliance with BD quality policies, procedures, and practices as well as with all local, state, federal and BD safety regulations, policies and procedures

Leadership/Project Management

• Demonstrate strong accountability for successful completion of designated tasks
• Provide design control leadership to cross-functional teams comprising QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members
• Proactively develop, maintain & share technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices.

Minimum Qualifications

• BS degree in engineering (Mechanical or Biomedical) is required. A Master’s degree in engineering is preferred.
• Minimum of 4-6 years of engineering experience is required. Medical device design and development experience related to high-volume manufacturing is strongly preferred.

Experience To Include

• 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

Project Leadership And Management Experience Is a Preferred

• Strong design control experience
• Experience with developing innovative solutions to complex problems
• Strong understanding of DOE and statistical methods.
• Strong 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.
• 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