Description

Job Description:

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. 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.

This position is hybrid with an average of 3+ days of week at a client site in Boston, MA.

Job Description:

Utilizes technical expertise and project management skills to support client development projects in the medical device and combination product space. Principal-level candidates are expected to execute work independently and at a higher level than the basic responsibilities listed below.

Basic responsibilities include:

• 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 any of the following technical areas:

• 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.
• Conduct 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.
• Serve 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.

Aptitude and Skill Set:

• 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
• 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:

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:

• 5-10 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. 10+ years of experience required for Principal level consideration.
• Significant contributions to complex, multi-disciplinary development programs, pharmaceutical (drug product) development, in vitro diagnostic development, clinical development, or medical device/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.
• Management of direct reports is not in scope of this role at the time of hire. However, organizational growth may allow for the role to expand to managerial responsibility of direct reports. Successful candidates for this position will be experienced in leading and mentoring junior staff.

Region:

Boston, MA

Travel:

Travel may be necessary to support client work. Periodic visits (e.g. 1-2 visits per year) to Kymanox office(s) are required.

Career Development:

The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.

Compensation:

Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions. Eligible for incentive program after 6 months of outstanding work.

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.