Jobs and Careers

Principal Product Development Engineer/ Scientist

United States, United Statesfull_timeVerifiedPosted 13 Aug 2024

About the role

Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you’ve come to the right place. The Kymanox Product Development team is seeking experienced Product Development Engineer or Scientist with a strong technical and/or operations backgrounds in the pharmaceutical, biotechnology or medical device industries. Job Description: Utilizes expertise in technical leadership and program management to advance client product development projects in the medical device and combination product space. Basic responsibilities include:

Representing Kymanox to clients as a subject matter expert and thought leader.
Providing technical leadership, expertise, and direction to internal and external project teams.
Providing mentorship to junior staff.
Ensuring compliance to internal and client quality and regulatory standards and fostering a positive compliance culture.

Projects may include any of the following technical areas:

Evaluate client technical documentation and development strategy to provide clear, actionable recommendations for mitigation(s) of challenges.
Develop detailed project plans, schedules, and overall project strategy.
Oversee phase-appropriate client testing activities, including combination product and medical device design verification and human factors testing.
CMO due diligence, evaluation, and client representation
Process improvement and troubleshooting, tech transfer
Program management of technically complex, multi-year development programs
Lead and/or oversee the creation of technical documentation supporting product development efforts.
Regulatory evaluation, submission authorship and review
Expert-level statistical analysis of development and production data

Aptitude and Skill Set:

Versatile and adaptable technical skills
Able to execute high-profile activities with minimal supervision
Ability to think strategically
Extremely detail-orientated and highly organized
Managerial (i.e., “do things right”) and leadership (i.e., “do the right thing”) skills
Strong professional presence and presentation skills
Excellent written and oral English communication skills
A mindset of innovation and creativity
Comfortable providing feedback and influencing internal and external stakeholders
Seasoned soft skills – high EQ and team player
Ability to work effectively with remote team members and/or direct reports
Ability to motivate self and others
Tackle problems proactively, not waiting for problems to grow unnecessarily
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

Educational Background: Advanced degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required. Experience:

Minimum 15 years' experience (including advanced degrees) in product development and/or manufacturing in the pharmaceutical, biotechnology, diagnostic, combination product, and/or medical device sectors is required.