Senior Engineer, Device Development - Combination Products
Description
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 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 Senior Engineer, 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 Munich (DE), Bern (CH), and Lausanne (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.
This position will provide technical 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 medical device and combination product space, supporting our clients in the pharma, biotech, and medtech industry.
Primary Responsibilities:
- Participate in and support a matrixed team environment with organization and cross functional projects.
- Author and review 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.
- Provide sound quality and compliance expertise to support products in various stages of development.
- Contribute to the growth and success of organization. Support internal business initiatives to improve Kymanox process and practices and ensure conformance to both Kymanox and external compliance standards.
Minimum Qualifications:
- Bachelor’s or master’s degree in a scientific, engineering, or other technical discipline
- 8+ years of experience in the medical device, pharmaceutical, or combination products (this includes post graduate experience).
- Demonstrated level of aptitude and knowledge in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
- Experience with pre-filled syringes, autoinjectors, co-packaged kits, inhalers, other drug delivery platforms, and/or other combination product platforms is required.
- Track record includes design, development, submission, or manufacturing of medical devices and/or combination products.
- A working knowledge in design controls, risks management, regulatory affairs, and quality engineering.
- Understanding of the regulatory landscape and familiar with Quality Management System Requirement, ICH guidelines, GMP, medical device and combination product best practices, standards, and regulations.
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.
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.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
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.