Senior Lab Engineer - Design Verification Testing
About The Position
The Senior Lab Engineer works under the direction of the Lab Manager to assist with test equipment qualifications, test fixture and jig design, test method development, and test method validations. The role applies analytical and engineering skills, leadership, and mentoring to development projects at West, particularly for needle-based injection systems. The engineer coordinates testing with project managers and verification engineers, assigns laboratory resources, and leads laboratory technicians through test execution. The role also supports project scope and timeline development, creates test programs for tensile and compression testing machines, qualifies laboratory equipment and environmental chambers, and authors and executes test procedures, validation documentation, and equipment qualification documentation. The position is onsite five days per week and includes occasional travel to external laboratories to support design verification testing. Travel is listed as 10%, up to 26 business days per year.
Requirements
- Bachelor’s degree in engineering or equivalent experience.
- Minimum 5 years of experience in a regulated engineering environment.
- Excellent analytical, problem-solving, and engineering skills.
- Excellent communication and interpersonal skills.
- Excellent technical writing skills, including experience authoring SOPs, work instructions, protocols, and reports.
- Proficiency in Microsoft Office, including PowerPoint, Word, Excel, and Outlook.
- Ability to work in a fast-paced environment with minimal supervision and guidance.
- Proven mechanical ability and troubleshooting skills are desired.
Nice To Haves
- Mechanical engineering or biomedical engineering degree.
- Experience with GMP, medical devices, and needle-based injection systems.
- Proficiency in statistical data analysis using software such as Minitab.
- Strong leadership and mentoring qualities, including mentoring junior-level engineers.
- Experience using and programming Instron and Zwick machines.
- Proficiency in CAD design and drafting in SolidWorks.
- Knowledge of ISO standards for Quality Management Systems for Medical Devices and needle-based injection systems.
Responsibilities
- Provide subject matter expertise, leadership, and mentoring in developing test methods and planning and coordinating test method validations for needle-based injection systems.
- Ensure laboratory procedures comply with the global Quality Management System and OSHA, local, state, and federal environmental regulations.
- Create test programs on tensile and compression testing machines.
- Ensure laboratory equipment and environmental chambers receive appropriate qualification for their intended use.
- Author and execute test method procedures, test method validation protocols and reports, and equipment qualification protocols and reports.
- Coordinate testing needs with project managers and verification engineers, then assign appropriate resources with laboratory staff.
- Plan, schedule, and lead laboratory technicians in executing laboratory tests.
- Participate in developing project scope and timelines during project core team meetings.
- Assist with designing, troubleshooting, and testing laboratory fixtures and jigs for test method development.
- Draft engineering drawings of fixtures and jigs for manufacturing.
- Manage CAD models and drawing revisions.
- Travel occasionally to support design verification testing with external laboratories.
- Identify inefficiencies and improve processes and procedures to streamline workflows and increase effectiveness.
- Author new laboratory SOPs and revise existing SOPs.
- Maintain a clean, tidy, and audit-ready laboratory environment.
- Demonstrate a customer-service attitude when interacting with internal and external customers.
- Comply with applicable regulations, policies, work procedures, instructions, and safety rules.
Benefits
- Volunteer opportunities through West without Borders and other charitable programs.
- Professional growth opportunities through training programs, tuition assistance, leadership development, and skill-certification initiatives.
- Flexible vacation, personal, and holiday leave.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
