Manager Device Development Combination Products (Remote)

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 that 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.

Kymanox is hiring a Manager, Device Development- Combination Products in a hybrid-remote role based in Germany or Switzerland. We offer a motivating and dynamic work environment with a growing team with offices in Bern (CH), Lausanne (CH), and Munich (DE). 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.

This position will provide both technical and managerial leadership to junior resources through both a direct and indirect reporting structure. This position will help lead strategic development projects by providing professional knowledge and experience in the biologics and combination product space, as well as assist with planning and hands-on responsibilities supporting clients.

Primary Responsibilities

• Provide both technical and managerial leadership to colleagues through both direct and indirect reporting structure. Responsible for mentoring and coaching, performance evaluations, resource management, goal setting, and reporting. May lead the German office, e.g. as General Manager.
• Invest in the professional growth and development of team members and strive to build a positive team culture.
• Planning and executing engineering activities and writing technical documentation to support client development projects. Directly support and provide subject matter expertise related to a range of engineering disciplines. Provide sound quality and compliance expertise to support products in various stages of development.
• Contribute to the growth and success of the organization. Support internal business initiatives to improve Kymanox processes and practices and ensure conformance to both Kymanox and external compliance standards.
• Provide regular updates to functional area-management, to facilitate timely decision-making and prioritization of project activities and deliverables.

Minimum Qualifications

• Bachelor’s or master’s degree in a scientific, engineering, or other technical discipline
• 5+ years of experience in the combination products, medical device and/or pharmaceutical/drug sectors
• Track record includes design, development, submission, or manufacturing of medical devices and/or combination products. A working knowledge in design controls, risk management, regulatory affairs, and quality engineering. Familiar with Quality Management System Requirements, ICH guidelines, GMP, medical device and combination product best practices, standards, and regulations.
• Proven experience in leadership, ideally both in direct and indirect reporting structure. Value a collaborative work environment where team members are encouraged to grow, take responsibility, feel accountable, and support each other. Comfortable taking initiative and driving positive change with a proactive and can-do attitude.

Travel

This role will require regular visits to our offices in Bern or Munich.

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About Kymanox

Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.

By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pride… because patients deserve better.

Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.