(Contract) Combination Product - Principal Product Development Engineer/Scientist

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. The Kymanox Product Development & Commercialization team is seeking an experienced (Contract) Principal Product Development Engineer or Scientist with a strong technical and/or operations backgrounds in the pharmaceutical (combination product), biotechnology or medical device industries. Job Description: Leverages expertise in technical leadership and cross-functional management to advance, de-risk, and deliver successful outcomes for clients' medical device and combination product development programs. Basic responsibilities include: • Representing Kymanox to clients as a subject matter expert and thought leader. • Providing technical leadership and direction to internal and external project teams. • Maintaining conformance to internal and client quality management systems. • Adhering to regulatory standards and promoting a positive compliance culture. • Providing mentorship to junior staff. Projects 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. • Conduct competitive landscape assessments and market analyses for delivery devices, contract organizations, and novel technologies • 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 • Expert-level statistical analysis of development and production data, strong preference for experience in reliability • Contract Manufacturing Organization (CMO) evaluation, due diligence, and selection on behalf of clients. • Support process development, improvement, and troubleshooting, • Engage with external partners to facilitate tech transfer • Provide technical support for regulatory submission preparation and review • Serve as an independent reviewer for client design review meetings throughout the product development process Aptitude and Skill Set: • Versatile and adaptable technical skill set • Executes high-profile activities with minimal supervision • Skilled in strategic planning and translating strategy into actionable processes • Operates effectively within multiple client quality systems and product development frameworks concurrently • Highly detail-orientated and organized • Strong professional presence with excellent presentation skills • Confident in providing feedback and influencing internal and external stakeholders • Collaborates effectively with remote team members and direct reports • Self-motivated and inspires others to achieve goals • Proactively identifies and resolves issues before they escalate • Demonstrates both managerial (i.e., "do things right") and leadership (i.e., "do the right thing") skills • Excellent verbal and written communication skills in English • Innovative and creative mindset with a focus on continuous improvement • Seasoned soft skills - high emotional intelligence (EQ) and strong team player • Technologically savvy, comfortable with modern IT tools and productivity software • Thrives in fast-paced, dynamic, and growth-oriented environments • Experienced engaging subject matter experts and effectively leveraging their input • Understands and values quality and regulatory compliance • Uncompromising honesty and integrity Educational Background: Advanced degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required. Experience: • Minimum 15 years' experience in product development and/or manufacturing in the pharmaceutical (combination product), biotechnology, diagnostic, and/or medical device sectors is required. • Leadership of complex, multi-disciplinary development programs, pharmaceutical (combination product) development, in vitro diagnostic development, clinical development, or electromechanical systems development is desirable. • Experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable. • Experience working in professional services is favorable. • 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. Region: Kymanox Corporate HQ in Morrisville, NC or King of Prussia, PA preferred. Travel: Travel may be necessary to support client work. If the candidate is not local to Kymanox headquarters in RTP, North Carolina, periodic visits (e.g.: 2 to 4 visits per year) are required. Compensation: Pay rate is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions. 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. Employment Type: Contractor Apply tot his job