Senior Combination Product Engineer/Senior Engineer
Kymanox
Summary
The Kymanox Product Development & Commercialization team is seeking a Senior 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.
Job description
Responsibilities
- Utilize technical expertise and project management skills to support client development projects in the medical device and combination product space
- Write technical documentation with minimal direction
- Conduct laboratory testing and data analysis
- Represent Kymanox and work product in client-facing meetings
- Perform basic project management (meeting minutes, schedules, correspondence)
Potential Project 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 and manage 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 with 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
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
- 7+ years of experience (including advanced degrees) in product development and/or manufacturing in the combination product, medical device, pharmaceutical, biotechnology, and/or diagnostic sectors
- 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
- Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required
- Excellent written and oral English communication skills
- Strong professional presence and presentation skills
- Extremely detail-oriented and highly organized
- Ability to work effectively with remote team members
- Flexible to be present at client sites and sometimes travel
Benefits
- Medical, Dental & Vision
- Short & Long-Term Disability
- Life Insurance
- 401(k) Matching
- Continuing Education Assistance
- Incentive Program
Company overview
Kymanox is a professional services company specializing in the life sciences industry, providing comprehensive solutions to support pharmaceutical, biotechnology, and medical device companies. The company offers a range of technical and operational services designed to accelerate product development and commercialization processes. Kymanox focuses on delivering expertise in areas such as process development, quality assurance, regulatory compliance, and technical operations. Their services are tailored to help clients navigate complex challenges in bringing innovative therapies and medical products to market. With a commitment to quality and efficiency, Kymanox serves as a strategic partner for life science organizations seeking to optimize their development pipelines and ensure successful product launches. The company's professional services model enables clients to access specialized expertise without the need for extensive internal infrastructure investments.