Product Development Engineering Senior Scientist - Medical Device & Combination Products

Job Description Job Description The Product Development Engineering Senior Scientist focuses on combination product development, with a particular focus on drug delivery systems. The Product Development Engineering Senior Scientist will work closely with Research and Development, Device Quality Control, Device Quality Assurance, Process Development, Clinical/Commercial Packaging & Labeling Functions, Regulatory Affairs, and Manufacturing Functions, as required. Key Duties and Responsibilities: Collaborate with highly cross-functional teams to author the design history documentation of combination drug-device and/or biologic device products. Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments. Translates User Requirements into Design Requirements as appropriate. Correlates Design Inputs with Design Outputs and supports Design Verification and Validation Studies (as needed) to be executed both internally and externally. Leads Design Reviews to completion, ensuring compliance with internal procedures and external standards. Manage Change Control, Deviations and Non-conformances with Cross-Functional Team for Impact Assessment and Investigations, and manage timely completion of activities while ensuring updates are made to relevant documents in Design History File. Perform Design History File maintenance as required, including – as applicable – review and revision of all Design and Quality System Documentation. Display an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes. Aligns with User Requirements, Functional Requirements, and Design Inputs as appropriate. Must be familiar and adhere to C.T.Q. flow down. Knowledge and Skills: Proven experience with Medical Device and Combination Product Development including ownership and authorship of Design and Development file records and leading Risk Management initiatives. Working knowledge of development and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies. Able to present to cross-functional team for input, alignment, and design and risk file updates. Must have experience executing workstreams in highly matrixed environments. Experience with medical device and drug delivery packaging development, container closure integrity testing and mechanical performance testing. A thorough understanding of cGxP principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820. A strong understanding of statistical principles is required, as are strong technical writing and presentation skills. Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously. Must demonstrate strong interpersonal and teamwork skills. Education and Experience: PhD with 2+ years of experience, M.S with 5+ years, or B.S with 8+ years of experience. Degree in Engineering preferred but will consider other related disciplines. Experience developing drug delivery systems is strongly preferred. May require occasional travel to other Vertex locations Pay Range: $126,600 - $189,800 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.