Senior/Principal Engineer or Scientist, Combination Products

I s 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 / Principal 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). Direct experience with pre-filled syringes, autoinjectors, co-packaged kits, inhalers, other drug delivery platforms, and/or other combination product platforms is required. Strong track record across several of the Areas of Expertise listed above, with the ability to provide senior technical leadership and support within these areas. Experience working at startup companies or small biotech/pharma/med device companies and/or experience working in professional services is favorable. Desired Aptitude and Skill Set: Motivated team player with a high sense of ownership and willingness to learn Operates effectively within multiple client quality systems and product development frameworks concurrently with minimal supervision Self-motivated and inspires others to achieve goals Excellent verbal and written communication skills in English. Any other language is a plus. Strong professional presence and verbal presentation skills Collaborates effectively with remote colleagues and clients. Confident in influencing internal and external stakeholders Seasoned soft skills – high emotional intelligence (EQ) and strong team player Understands and values, quality and regulatory compliance Highly detail-orientated and organized Uncompromising honesty and integrity Travel: Up to 10% travel is possible. 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. About Kymanox: Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole. Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey. 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.