Senior Mechanical Engineer

Watertown, MA /
Research & Development /
Full-time
Are you interested in an engaging job and making a big impact in patient's lives?


Windgap Medical, Inc. (Watertown, MA) is a rapidly growing, private pharmaceutical company developing injection devices for self-administration and associated drugs. Windgap’s first product is a wet/dry autoinjector that delivers a proprietary epinephrine formulation for the treatment of anaphylactic shock. Windgap plans to leverage its injection platforms, formulation, and manufacturing expertise for additional indications. Windgap leads its development work by utilizing a team of Contract Manufacturing Organizations (CMOs) for all manufacturing operations along with Contract Research Organizations (CROs) for much of its pharmaceutical analytics.
 
Job Description:
Windgap is looking for a hands-on Senior Mechanical Engineer to support design and development efforts associated with autoinjector drug delivery devices. The candidate’s responsibilities will be divided between advancing a new product platform design (starting at an early proof-of-concept phase) and supporting products in late development stages. 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 in prototyping, design for manufacture, and design for assembly of complex mechanical devices in the medical field are a must.  Ideally the candidate would also have experience designing assembly equipment or electromechanical systems. 

The candidate will:

    • report to Windgap’s Director of Product Development
    • contribute to the early-stage development of customized wet/dry autoinjectors; focusing on mechanical and electromechanical systems, complex actuators, mechanism designs, testing instruments, and prototyping manufacturing methods
    • test, evaluate, and troubleshoot prototypes and then ideate, assess, and implement improvements
    • perform root cause analysis of manufacturing issues on mature products, prepare and execute relevant experiments, document results, and suggest paths forward
    • support reliability, testing, and manufacturing engineers as products advance through development stages
    • investigate and assess potential vendors and their capabilities for prototyping and production level manufacturing solutions
    • 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
    • establish individual and team goals consistent with overall project and company goals

Relevant experience:

    • BS in ME, BME, or similar required; MS preferred. Minimum of 5 years of working experience designing, building, and improving medical devices
    • Skilled in SolidWorks. Structural and dynamic finite element analysis as well as experience creating simulations in Excel a plus
    • Proven experience in prototyping, design for manufacture, and design for assembly of injection molded mechanical devices
    • Comfortable with all phases of product development lifecycle including concept generation, design, rapid prototyping, manufacturing, verification & validation, qualification, and transfer to production
    • Experienced with risk management in design including FTA, FMEA, and root-cause analysis
    • Experience managing projects in highly virtualized organizations while successfully engaging and managing external resources, worldwide
    • Preferably, experienced with electromechanical and pneumatic driven automation mechanisms
    • Preferably, experience with parenteral and injectable-related medical device component technologies such as cartridges, needles, plungers, and elastomeric coating technologies
    • Preferably, experience with drug/device combination products development
    • Preferably, experience with ISO 11608, 13485, and 14971 standards
    • Preferably, experience with designing hardware products in an FDA or other regulated industry
    • Preferably experience working on US Government contracts
    • Experience with MS Office, including email, word processing, spreadsheets, project management and presentation tools
    • Some travel required
Windgap Medical, Inc. 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.

Thank you for considering Windgap Medical. We will review your qualifications and contact you if we would like to talk more.

Sincerely,

The Windgap Medical Team