This is an onsite position requiring the team member to be onsite 5 days a week. Job SummaryIn this role, the Senior Lab Engineer will work under the direction of the Lab Manager to assist with test equipment qualifications, test fixture/jig design, test method development, and test method validations. This individual will bring excellent analytical and engineering skills, as well as leadership and mentoring talent to the execution of development projects at West.
Essential Duties and Responsibilities- Provides subject matter expertise, leadership, and mentoring in the development of test methods, as well as the planning and coordination of test method validations for needle-based injection systems.
- Ensure Laboratory procedures are compliant with global Quality Management System, OSHA, local, state and federal environmental regulations.
- Creates test programs on tensile/compression testing machines.
- Ensures lab equipment and environmental chambers receive the appropriate level of qualification for their intended use.
- Authors and executes test method procedures, test method validation protocols/reports, and equipment qualification protocols/reports
- Works outwardly with Project Managers and Verification Engineers to plan and coordinate testing needs, and then inwardly with lab staff to assign appropriate resources.
- Planning, scheduling, and leading Lab Technicians through execution of laboratory tests.
- Participates in the development of project scope and timeline in project core team meetings.
- Assists in the designing, troubleshooting, and testing of laboratory figures and jigs as part of test method development activities.
- Drafts engineering drawings of fixtures and jigs for manufacturing.
- Manages CAD models and drawing revisions.
- Occasional travel to support design verification testing with external laboratories.
- Recognizes inefficiencies and takes initiative to improve processes and implement procedures to streamline workflows and increase effectiveness. Authors new and revises existing lab SOPs.
Preferred Knowledge, Skills and Abilities- Proficiency in statistical data analysis using software packages such as Minitab.
- Strong leadership qualities and mentorship to junior level engineers.
- Excellent problem-solving skills as well as keen analytical abilities.
- Excellent communication and interpersonal relations skills.
- Excellent technical writing skills with experience authoring SOPs, work instructions, protocols, and reports.
- Proficiency in MS Office suite including PowerPoint, Word, Excel and Outlook.
- Experience using and programming Instron and Zwick machines a plus.
- Proficiency in CAD design and drafting in SolidWorks a plus
- Knowledge of specific ISO standards - Quality Management Systems for Medical Devices and needle-based injection systems a plus.
- Works well in a fast-paced environment, with minimal supervision and guidance.
- Track record of proven mechanical ability and troubleshooting skills is desired.
Additional Responsibilities- Maintains a clean and tidy laboratory environment that is audit-ready at all times.
- Demonstrates a "Customer Service" attitude when interacting with internal and external customers
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
Education- Bachelor's degree in engineering or equivalent experience required (mechanical engineering or biomedical engineering preferred)
Work Experience- Minimum 5 years of experience in a regulated engineering environment.
- Work experience with GMP, medical devices, and needle-based injection systems preferred.
Travel Requirements10%: Up to 26 business days per year
Physical RequirementsMedium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.
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