Engineer, PD&C

Kymanox•Boston, MA

2d•Hybrid

About The Position

Kymanox is seeking a Combination Product Engineer or Scientist with a strong technical and/or operations background in the pharmaceutical, biotechnology, diagnostics, or medical device industries. Ideal candidates will build on their proven past performance supporting complex product development or life cycle management programs involving drug-device combination products, Class 1/2/3 medical devices, and/or in vitro diagnostics. This position is hybrid with an average of 3 days of week at a client site. The role utilizes technical expertise and project management skills to support client development projects in the medical device and combination product space. Projects may include creating technical documentation supporting product development efforts, technology evaluation, due diligence, and selection, CMO due diligence, evaluation, and client representation, regulatory submission authorship, conducting testing activities, and statistical analysis of development and production data.

Requirements

Minimum bachelor's degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution.
2-5 years of experience (including advanced degrees) in product development and/or manufacturing in the combination product, medical device, pharmaceutical, biotechnology, and/or diagnostic sectors is required.
Demonstrated contributions to complex, multi-disciplinary development programs, pharmaceutical (drug product) development, in vitro diagnostic development, clinical development, or electromechanical systems development is desirable.
Versatile and adaptable technical skills
Positive attitude, and welcomes new challenges
Flexible to be present at client sites and sometimes travel
Able to execute activities with minimal supervision, manages time wisely
Strong professional presence and presentation skills
Extremely detail-orientated and highly organized
Excellent written and oral English communication skills
Comfortable providing feedback and influencing internal and external stakeholders
Emotionally stable and can navigate challenging clients and situations
Seasoned soft skills – high EQ and team player
Ability to work effectively with remote team members
Tackle problems proactively
A mindset of innovation and creativity
Computer and IT savvy
Thrive in a fast-paced, growing, and dynamic work environment
Expertly solicit and utilize subject matter expert input
Value and understand quality
Uncompromised honesty and integrity

Nice To Haves

Early career master's and Ph.D. level candidates encouraged to apply.
Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.
Experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable.

Responsibilities

Writing technical documentation with minimal direction.
Conducting laboratory testing and data analysis.
Representing Kymanox and work product in client-facing meetings.
Basic project management (i.e., meeting minutes, schedules, correspondence).
Creating technical documentation supporting product development efforts, including design and development files and technical files.
Technology evaluation, due diligence, and selection.
CMO due diligence, evaluation, and client representation.
Regulatory submission authorship.
Conducting testing activities, including combination product and medical device design verification and human factors testing.
Statistical analysis of development and production data.