Sr Test Engineer (Manufacturing)

JobDiva, Inc.; Lafayette (CO); Hybrid; USD 76,000 - 90,000; Full time

Job summary

Primary Talent Partners is seeking a Sr Test Engineer (Manufacturing) in Lafayette, CO for a 12-month contract in the Neuromodulation Interventional line. The role focuses on system verification and validation for interventional medical devices, partnering with multiple engineering functions to drive robust V&V strategies.

The candidate will develop verification plans and protocols, write validation reports, and support design reviews and risk management.

Qualifications

• Bachelor's degree in engineering or scientific discipline with 6+ years of testing/engineering experience or Advanced Degree with 4+ years of experience.
• Experience leading system-level verification planning, execution, and documentation.
• Experience supporting system-level validation planning, execution, and documentation.
• Experience testing devices in ex-vivo tissue.
• Basic knowledge of mechanical and electrical engineering fundamentals.
• Familiarity with IEC 60601 testing standards and electrical safety/EMC testing.

Responsibilities

• Develop verification plans and protocols with sample size justification and acceptance criteria.
• Drive design input verification for sterilized disposable instruments and device components.
• Develop test methods, validation plans, and validation reports.
• Document verification evidence for regulatory submission readiness.
• Support design validation with end-user testing in real or simulated environments.
• Collaborate with quality, systems, mechanical, electrical engineering teams, and suppliers.
• Communicate findings and provide senior technical leadership across teams.

Skills

Verification & Validation

System-level testing

Test method development

Regulatory documentation

Cross-functional teamwork

Execution discipline

Education

Bachelor's degree in engineering or scientific discipline

Advanced degree in engineering or scientific discipline

Tools

Instron

Multimeter

Job description

Primary Talent Partners has a new contract opening for a Sr Test Engineer (Manufacturing) with our medical device client in Lafayette, CO. This is a 12-month contract with a potential for extension.

Pay:

$55.00 - $65.00/hr;W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Schedule:

Hybrid - 4 days in office, 1 day remote

Description:

As a Test Engineer within the Neuromodulation Interventional organization, you will utilize your expertise in test and engineering to delivering cutting edge products that focus on ablating tumors in patients.

A DAY IN THE LIFE

Within our R&D Department in Neuromodulation, this employee will be part of a team that defines, develops and tests new products for the Neuromodulation business.

The position responsibilities will primarily focus on system verification and validation (V&V) for Interventional products. This role is integral in the development cycle of any new product within this business. They will be responsible for partnering with Systems Development engineering lead and design teams, Quality engineers and Program managers to drive meaningful design inputs, robust designs and ultimately an efficient and effective V&V strategy. The position offers excellent opportunity for an engineer interested in defining and executing V&V strategies with robust test method validations to produce reliable and successful products. Candidates should have demonstrated ability to execute independently after receiving high level scope and constraints.

Employee responsibilities may include the following:

• Develop comprehensive plans for verification testing, including test method validation
• Create verification protocols with sample size justifications and acceptance criteria definitions
• Drive design input verification for sterilized disposable instruments, including but not limited to system compatibility, reliability, mechanical and tissue performance, partnering with design quality, systems, mechanical and electrical engineering partners and laboratory technicians
• Develop test methods, test method validation plans, and test method validation reports
• Clearly document a verification body of evidence through regulatory submission ready engineering reporting
• Support design validation of user needs with real end-users in real or simulated use environments
• Support design reviews and risk management activities
• Partner with manufacturing, quality, marketing, human factors, and regulatory teams to ensure the design is verified in compliance with medical device standards
• Execute minimally invasive therapy procedures and products in soft tissue per medical device standards and internal procedures
• Effectively communicate and present test findings, analysis and conclusions cross-functionally
• Provide senior-level technical leadership to internal engineers and external development partners

QUALIFICATIONS SECTION

Must Have: Minimum Requirements

• To be considered for this role, please ensure the minimum requirements are evident on your resume.
• Bachelor's degree in engineering or scientific discipline and 6+ years experience in technical testing or engineering experience OR
• Advanced Degree in engineering or scientific discipline and 4+ years experience in technical testing or engineering experience
• Experience leading system-level verification planning, execution, and documentation
• Experience supporting system-level validation planning, execution, and documentation
• Experience testing devices in ex-vivo tissue
• Basic knowledge of mechanical and electrical engineering fundamentals
• Basic knowledge of mechanical and electrical test equipment (ex. Instron, multimeter, etc.)
• Demonstrated ability to work both independently and in a cross-functional team environment
• Strong organization, prioritization, and communication skills

Desired/Preferred qualifications:

• History working in regulated industries such as medical, aerospace or defense
• Knowledge of IEC 60601 testing standards
• Knowledge of electrical safety testing and EMC testing
• Familiarity with Design for Reliability and Manufacturability (DRM) best practices (6 sigma)
• Experience performing system design input tracing to test results
• Experience working on systems that have mechanical, electrical and software elements
• Experience owning the systems engineering execution across the full V-model lifecycle

Top 3 technical skills that are required for the role:

1. Verification & Validation Strategy Leadership
2. Test Method Development & Validation Expertise
3. Execution Discipline & Regulatory Documentation

Primary Talent Partners is an Equal Opportunity / Affinative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail]

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