Sr Test Engineer

Planet Pharma; Lafayette (CO); On-site; USD 85,000 - 110,000; Full time

Job summary

Planet Pharma is seeking an experienced Test Engineer in Lafayette, Colorado, focused on verification and validation strategies for their Neuromodulation Interventional team. Candidates will bring 4+ years of experience with an advanced degree or 6+ years with a bachelor's in engineering, contributing to breakthrough medical products.

This role entails developing comprehensive verification test plans, leading validation efforts, and supporting compliance with medical device standards.

Qualifications

• 6+ years experience in technical testing or engineering.
• 4+ years experience with an advanced degree in testing.
• Experience leading system-level verification planning.
• Experience supporting system-level validation documentation.
• Basic knowledge of mechanical/electrical test equipment.

Responsibilities

• Develop plans for verification testing with method validation.
• Create verification protocols, sample size justifications.
• Drive design input verification for disposable instruments.
• Develop test methods, validation plans, and reports.
• Document verification evidence for regulatory submissions.
• Support design validation with end-users.
• Partner with teams to ensure design compliance.

Skills

Verification & Validation Strategy

Test Method Development

Execution Discipline

Regulatory Documentation

Mechanical Engineering Fundamentals

Electrical Engineering Fundamentals

Organizational Skills

Communication Skills

Education

Bachelor’s degree in engineering or scientific discipline

Advanced Degree in engineering or scientific discipline

Tools

Instron

Multimeter

Job description

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

Education Required/Years’ Experience Required:

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

At this company, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

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.

This company has been shaping the approach to minimally invasive tumor treatment for over 25 years and is redefining standard of care for metastatic cancer in the liver with a revolutionary microwave ablation system. The Interventional team also invented the first balloon kyphoplasty devices for the treatment of vertebral compression fractures and continue to deliver breakthrough innovative RF ablation systems to treat metastatic and benign spinal tumors and alleviate chronic pain through targeted nerve ablation.

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