Product Development Engineering Scientist

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 105,600 - 158,400; Full time

Benefits offered by this job

Annual bonus

Equity awards

Total Rewards benefits

Job summary

Vertex Pharmaceuticals LLC in Boston seeks a Product Development Engineering Scientist to advance combination drug-device products. You will collaborate across R&D, Quality, Regulatory, and Manufacturing to translate requirements into designs and maintain the Design History File.

You will author risk analyses (DFMEA, PFMEA), perform verifications, manage change control, and ensure adherence to cGxP, ISO 13485, and 21 CFR 820.

Qualifications

• Experience with Medical Device Development including ownership and/or authorship of Design History File records and Risk Management deliverables.
• Experience with medical device packaging development and mechanical performance testing is preferred.
• Working knowledge of Test Methods for selection, verification and validation of components, sub-systems and assemblies.
• A strong 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.

Responsibilities

• Collaborate with cross-functional teams to author the Design History File records and Risk Management deliverables.
• Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments.
• Translate User Requirements into Design Requirements and support Verification and Validation studies as needed.
• Manage Change Control, Deviations and Non-conformances with Cross-Functional Team for Impact Assessment and Investigations.
• Display attention to detail to ensure complete design history documentation for Process Development and Manufacturing.

Skills

Cross-functional collaboration

Technical writing

Risk management

Statistical analysis

Presentation skills

Education

Engineering degree

PhD with 0-3 years

MS with 3+ years

BS with 6+ years

Job description

## Product Development Engineering ScientistApplylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29341**Job Description****General Summary:**The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems. The Product Development Engineering 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.* 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.**Knowledge and Skills:*** Proven experience with Medical Device Development including ownership and/or authorship of Design and Development file records and Risk Management deliverables.* Experience with medical device packaging development and mechanical performance testing is preferred.* Working knowledge 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.* A strong 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.**Education and Experience:*** Degree in Engineering preferred but will consider other related disciplines* PhD with 0-3 years of experience, M.S with 3+ years, or B.S with 6+ years of experience.**Pay Range:**$105,600 - $158,400**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 [e-mail]