Combination Product Senior/Principal Engineer or Scientist

About the role

The Kymanox Product Development & Commercialization team is seeking a Senior/Principal Combination Product Engineer or Scientist with a strong technical and/or operations background in the pharmaceutical, biotechnology, diagnostics, or medical device industries.

Responsibilities

• Utilizes technical expertise and project management skills to support client development projects in the medical device and combination product space.
• Writing technical documentation with minimal oversight or guidance.
• Working cross-functionally within and outside Kymanox.
• Acting as technical lead on small programs or leading workstreams on larger programs.
• Mentoring junior technical staff and reviewing their work prior to client delivery.
• Adhering to regulatory standards and promoting a positive compliance culture.
• Basic project management (i.e., meeting minutes, schedules, correspondence).
• Projects may include evaluating client technical documentation and development strategy to provide clear, actionable recommendations for mitigation(s) of challenges.
• Creating technical documentation supporting product development efforts, including design and development files and technical files.
• Conducting competitive landscape assessments and market analyses for delivery devices, contract organizations, and novel technologies.
• Technology evaluation, due diligence, and selection.
• CMO due diligence, evaluation, and client representation.
• Developing detailed project plans, schedules, and overall project strategy.
• Serving as an independent reviewer for client design review meetings throughout the product development process.
• Post-market design change assessments, technical evaluation and implementation, and commercialization.
• 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

• Versatile and adaptable technical skills.
• Able to execute high-profile activities with minimal supervision, manages time wisely and delegates as necessary.
• Positive attitude, and welcomes new challenges.
• Flexible to be present at client sites and sometimes travel.
• 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.
• Proficient in hands-on lab operations and competent in GLP/ GDP.
• Computer and IT savvy.
• Thrives 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.

Skills

• Technical expertise in the pharmaceutical, biotechnology, diagnostics, or medical device industries.
• Experience in product development and/or manufacturing in the combination product, medical device, pharmaceutical, biotechnology, and/or diagnostic sectors.
• Significant contributions to complex, multi-disciplinary development programs, pharmaceutical (drug product) development, in vitro diagnostic development, clinical development, or medical device/electromechanical systems development.
• Experience working at startup companies or small biotech/pharma/med device companies.
• Familiarity with government and private sector funding mechanisms.
• Management of direct reports is not in scope of this role at the time of hire.

Benefits

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