Senior Engineer/Engineer or Scientist, Combination Products

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 who 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 Europe Team is seeking an experienced Senior Engineer/Engineer with a strong technical and/or operations background in the pharmaceutical (combination product), biotechnology or medical device industries.
We offer a motivating and dynamic work environment with a growing team with offices in Munich (DE) and Bern (CH). Our organization provides ample growth opportunities to help you advance in your career. Enjoy the benefits of flexible work hours and a hybrid working model.
Responsibilities:
Provides technical leadership to client-facing Kymanox project teams with accountability for project strategy, execution, success, and client satisfaction.
Plans and ensures execution of combination product development activities. Monitors and supports-hand on quality and progress of work, providing technical support and direction to project teams and individuals.
Author and/or reviews technically complex documentation to ensure compliance with relevant standards and regulations.
Directly support and provide subject matter expertise related to a range of engineering disciplines.
Proactively manage client relationships and ensure client satisfaction
Contribute to the growth and success of the organization. Identifies and supports internal business initiatives to improve Kymanox processes and practices.
Provides mentorship and development opportunities to junior resources, as part of cross-functional projects.
Ensures conformance to both Kymanox and external compliance standards.
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 1-5 direct reports. Successful candidates for this position will be experienced in leading and mentoring junior staff.
Area of expertise May Include Any Of The Following Technical Areas:
Evaluate client technical documentation and strategy to provide clear, actionable recommendations for product design, development, and commercialization activities.
Provide Quality Engineering support across product development activities, including design controls, process development, deviation investigations, CAPAs, and compliance with applicable quality system requirements.
Conduct competitive landscape assessments and market analyses for delivery devices, contract organizations, and novel technologies.
Serve as a device lead for combination product development programs, with a good understanding of Chemistry, Manufacturing, and Controls (CMC) requirements across clinical and commercial stages.
Prepare detailed project plans, schedules, and overall development strategy.
Management of technically complex, multi-year development programs.
Oversee the creation of technical documentation supporting design controls, manufacturing processes, and regulatory submissions.
Lead the preparation of risk management file documentation.
Oversee phase-appropriate client testing activities, including combination product and medical device design verification and human factors testing.
Direct design verification and the associated test method development and validation activities.
Contract Manufacturing Organization (CMO) evaluation, due diligence, and selection on behalf of clients.
Provide Regulatory Affairs support for clinical and commercial submissions, including submission strategy, technical documentation review, and coordination of global regulatory deliverables.
Educational Background:
The candidate will have at minimum a bachelor’s degree in engineering such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering, or a science-related field.
Experience:
8+ years’ experience in the medical device, pharmaceutical, or combination products industry (this includes post graduate experience).