(Contract) Engineer, PD&C

Job Description

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 direction.
• Conducting laboratory testing and data analysis.
• Representing Kymanox and work product in client-facing meetings.

Basic Responsibilities

• 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.

Aptitude And Skill Set

• 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
• Able to provide feedback and influence internal and external stakeholders
• Emotionally stable and can navigate challenging clients and situations
• Seasoned soft skills – high EQ and team player
• Able to work effectively with remote team members
• Tackle problems proactively
• A mindset of innovation and creativity
• Computer and IT savvy
• Thrives in a fast-paced, growing, and dynamic work environment
• Expertly solicit and utilize subject matter expert input and understand quality
• Uncompromised honesty and integrity

Education

• 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.

Experience

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

About Kymanox

Kymanox is a life sciences professional services company dedicated to helping life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. Kymanox provides professional services related to engineering, compliance, and project management, servicing clients ranging from Fortune 100 companies to virtual start-up companies. Founded in 2004, Kymanox has grown steadily since its inception, with corporate HQ in Research Triangle Park, NC, and offices in Boston, Chicago, Philadelphia, and New Jersey. To learn more, visit our website: Life Science Solutions | Kymanox. Kymanox is committed to equal opportunity employment and follows HR best practices in the Life Science industry.