Senior Combination Product Engineer/Senior Engineer

Kymanox

53d•Remote

About The Position

Kymanox is seeking a Senior Combination Product Engineer or Scientist / Senior Engineer or Scientist for its Product Development & Commercialization team. The role supports client development projects involving medical devices and combination products, using technical expertise and project management skills. Candidates should have a technical and/or operations background in the pharmaceutical, biotechnology, diagnostics, or medical device industries, with experience supporting complex product development or life cycle management programs. The position may involve creating product development documentation, evaluating technologies and contract manufacturing organizations (CMOs), authoring regulatory submissions, conducting design verification and human factors testing, and analyzing development or production data. The work may also include laboratory testing, client-facing meetings, and basic project management activities. This is a remote position. Travel may be necessary for client work, and periodic visits to Kymanox offices—approximately one or two per year—are required. The role may evolve over time as the company grows, with opportunities for additional responsibilities and advancement within the role or into other functions. Kymanox is a life sciences professional services company providing engineering, compliance, and project management services. Its teams work with clients ranging from large companies to virtual startups and support products in biotechnology, pharmaceuticals, medical devices, and combination products. The company describes a collaborative environment with opportunities to work across projects and develop expertise in its services and the life sciences industry.

Requirements

Bachelor’s degree or higher in natural sciences, such as chemistry or biology; engineering, such as chemical, biomedical, or mechanical engineering; or a related technical discipline from an accredited institution.
At least 7 years of experience, including advanced degrees, in product development and/or manufacturing in the combination product, medical device, pharmaceutical, biotechnology, and/or diagnostics sectors.
Versatile and adaptable technical skills.
Positive attitude and willingness to take on new challenges.
Ability to be present at client sites and travel when needed.
Ability to execute activities with minimal supervision and manage time effectively.
Strong professional presence and presentation skills.
Strong attention to detail and organizational skills.
Excellent written and oral English communication skills.
Comfort providing feedback and influencing internal and external stakeholders.
Ability to navigate challenging clients and situations with emotional stability.
Strong interpersonal skills, high emotional intelligence, and a team-oriented approach.
Ability to work effectively with remote team members.
Proactive problem-solving approach.
Innovation and creativity.
Computer and IT proficiency.
Ability to thrive in a fast-paced, growing, dynamic work environment.
Ability to solicit and use subject matter expert input effectively.
Commitment to quality, honesty, and integrity.

Nice To Haves

Early-career candidates with a master’s degree or Ph.D. are encouraged to apply.
Industry certificates in project management, such as PMP or CAPM, six sigma, quality, or regulatory affairs.
Demonstrated contributions to complex, multidisciplinary development programs, pharmaceutical drug product development, in vitro diagnostic development, clinical development, or electromechanical systems development.
Experience at startup companies or small biotechnology, pharmaceutical, or medical device companies.
Familiarity with government and private-sector funding mechanisms.

Responsibilities

Write technical documentation with minimal direction.
Conduct laboratory testing and analyze data.
Represent Kymanox and its work product in client-facing meetings.
Perform basic project management, including meeting minutes, schedules, and correspondence.
Create product development documentation, including design and development files and technical files.
Support technology evaluation, due diligence, and selection.
Conduct CMO due diligence and evaluation, and represent clients in related activities.
Author regulatory submissions.
Conduct testing activities, including combination product and medical device design verification and human factors testing.
Perform statistical analysis of development and production data.