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Senior R&D Engineer

1 month ago

Salt Lake City, United States MILLENNIUMSOFT Full time

Job Title – Senior R&D Engineer

Location – Salt Lake City, UT

Duration – 5+ Months

Total Hours/week - 40.00
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