We are looking for a hands-on, experienced Lead Test Engineer to support design and development efforts of mature and emerging products. The candidate’s primary responsibilities will focus on supporting development efforts of products in late development stages.

Responsibilities will include advancing a new product platform design starting at an early proof-of-concept phase. The candidate should be a flexible, self-starter, who is effective at managing their time to meet goals. They should also be comfortable investigating and executing a wide variety of tasks.

Experience working as a test engineer in the medical device field a must.

Ideally the candidate would also have experience conducting design verification efforts.

The Candidate

·       Will report to the Director of Product Development

·       Conduct, document, and present testing of a late-stage development product to ensure functionality and confirm all design inputs are met

·       Generate test plans and either carry out associated test methods or oversee the actions completed by a development partner (CMO)

·       Oversee and maintain the company’s  mechanical testing lab and the systems therein

·       Oversee the proper execution of design verification, validation, and reliability as conducted by contracted services

·       Interact with other company stakeholders to help define, document, analyze, perform, and interpret tests for products, systems, or components

·       Identify functional problems and aid with root cause analysis to suggests resolutions

·       Define internal quality control standards and the maintenance of reliability programs

·       Ensure testing procedures comply with relevant USP, ISO, ASTM and other regulatory standards and FDA guidances

·       Strategize and execute test, beta, and pilot builds, as needed

·       Develop close CMO relationships to allow for efficient inventory tracking, build record approval, and test plan approvals

·       Provide hands-on, troubleshooting, process, and manufacturing support to overcome design hurdles

·       Establish individual and team goals consistent with overall project and company goals

·       Contribute to the early-stage development of separate customized wet/dry autoinjector, focusing on mechanical/electromechanical systems, complex actuators, mechanism designs, testing instruments, and prototyping manufacturing tools

·       Be capable of working both independently and in a team, while being flexible, self-motivated, curious and willing to drive change in the drug delivery market

Relevant Experience

·       BS in ME, BME, or similar required, MS preferred.

·       Minimum of 5 years of working experience testing medical devices

·       Experience formulating and executing documentation to support characterization testing (i.e., Test Plans, Test Methods, Test Notes, and Test Reports)

·       Experience performing Gage R&R and test method validation using custom fixturing

·       Experience calibrating, validating, and maintaining test equipment, included but not limited to tensile testing, torque testing, drop testing, high speed video, metrology hardware and software

·       Experience writing and conducting equipment validation protocols for IQ/OQ/PQ

·       Experience testing in conformance with ISO 13485 and FDA 21 CFR Part 820

·       Experience with Minitab and an understanding of relevant statistics for product development

·       Comfortable with all phases of product development lifecycle including concept generation, design, rapid prototyping, manufacturing, verification & validation, qualification, and transfer to production

·       Preferably, experience with risk management in design including FTA, FMEA, and root-cause analysis

·       Preferably, experience with drug/device combination products development

·       Preferably, experience with parenteral and injectable-related medical device component technologies such as cartridges, needles, plungers, and elastomeric coating technologies

·       Preferably, experience with ISO 11608 and 14971 standards

·       Preferably, experience working on US Government contracts

·       Experience with MS Office, including email, word processing, spreadsheets, and presentation tools

The company offers a competitive benefits package including, medical, dental, disability, life insurance, 401K savings plan and is EOE/M/F/D/V employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Company is a rapidly growing, private pharmaceutical company developing injection devices for self-administration and associated drugs.