[Hiring] Combination Product Engineer/Senior Engineer @Kymanox

Role Description

The Kymanox Product Development & Commercialization team is seeking a Combination Product Engineer or Scientist / Senior 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.

Utilizes technical expertise and project management skills to support client development projects in the medical device and combination product space. Basic responsibilities include:

• 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).

Projects may include any of the following technical areas:

• 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.

Qualifications

• 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.
• 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.

Requirements

• 2-8 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.
• Experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable.
• 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-oriented 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.

Benefits

• Medical healthcare including dental and vision.
• Short- and long-term disability.
• Life insurance.
• Matching 401(k) retirement plan.
• Continuing education assistance.
• Other benefits.