Medical Device & Combination Product Development, Associate Director

Vertex Pharmaceuticals Inc (US); United States; On-site; USD 183,000 - 248,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

Educational assistance

Commuting subsidy

401(k) and equity

Job summary

Vertex Pharmaceuticals in the United States seeks an Associate Director to lead drug-delivery device and combination-product programs from feasibility to commercialization readiness. This hands-on role integrates device engineering, software, human factors, clinical needs, and regulatory strategy to deliver safe, reliable, patient-centered solutions.

The role requires deep experience in device architecture, risk management (FMEA, ISO 14971), and regulatory submissions across FDA pathways, with

Qualifications

• Minimum of 10 years in medical device development (8 years with MS, 6 years with PhD).
• BS or MS in engineering or related discipline required.

Responsibilities

• Lead device and combination-product development from feasibility to commercialization.
• Define integrated development strategies addressing requirements, usability, reliability, manufacturability, and regulatory expectations.
• Translate clinical requirements and user needs into system, software, interface, and component design inputs.
• Provide technical leadership for device architecture and delivery performance.
• Lead design-control activities including DHF documentation and risk management.

Skills

Drug-delivery systems

Design controls

Systems engineering

Regulatory knowledge

Risk management

Software verification

Leadership

Matrix collaboration

Education

Bachelor's or Master's in engineering

Tools

IEC 62304

ISO 13485

FDA 21 CFR Part 4

IEC 60601

Job description

Job Description General Summary

The Medical Device & Combination Product Development, Associate Director is a hands‑on technical leader responsible for advancing drug‑delivery device and combination‑product programs supporting Vertex therapies. This player‑coach role leads the development of mechanical, electromechanical, wearable, on‑body, and connected delivery systems. The successful candidate will integrate device engineering, software, human factors, clinical needs, quality requirements, manufacturing considerations, and regulatory strategy to deliver safe, reliable, patient‑centered solutions from feasibility through commercialization readiness.

Key Duties and Responsibilities

• Lead device and combination‑product development activities from early feasibility through clinical development and commercialization readiness.
• Define integrated development strategies that address product requirements, user needs, delivery performance, usability, reliability, manufacturability, and regulatory expectations.
• Translate intended use, clinical requirements, and user needs into clear system, software, interface, and component design inputs.
• Provide technical leadership for device architecture, delivery performance, connectivity, user interfaces, and accessories.
• Lead design‑control activities, including development plans, design inputs and outputs, traceability, design reviews, verification and validation, risk management, design changes, and Design History File documentation.
• Apply risk‑management principles in accordance with ISO 14971, including hazard analyses, FMEAs, use‑related risk analyses, risk controls, and benefit‑risk assessments.
• Develop and oversee risk‑based verification and validation strategies for functional, mechanical, electrical, software, transportation, reliability, compatibility, and delivery‑performance testing.
• Partner with Human Factors and Usability Engineering to plan and execute formative and summative usability evaluations.
• Support clinical‑use readiness, including device configuration, labeling, instructions for use, packaging, training materials, clinical documentation, and complaint workflows.
• Partner with suppliers to integrate design and development activity for connected drug delivery systems.
• Ensure lifecycle, interoperability, and change‑control requirements are incorporated throughout development.
• Collaborate with Quality Assurance, Regulatory Affairs, Clinical, Pharmaceutical Sciences, and Drug Product Development teams.
• Mentor and develop engineers and technical staff while providing hands‑on technical contributions and clear accountability across matrixed teams.

Knowledge and Skills

• Demonstrated experience developing drug‑delivery systems, including infusion, wearable, on‑body, and/or large‑volume delivery devices.
• Experience leading medical‑device and combination‑product design controls, including requirements management, traceability, Design History File (DHF) documentation, and design‑change control.
• Strong knowledge of drug‑device system architecture and requirements engineering.
• Deep working knowledge of ISO 13485 quality‑management systems, ISO 14971 risk management, FDA combination‑product requirements under 21 CFR Part 4, and applicable FDA medical‑device quality‑system requirements.
• Experience developing and executing design verification, design validation, and risk‑based test strategies, including reliability, robustness, environmental, transportation, and delivery‑performance testing.
• Experience in mechanical and electromechanical device development.
• Experience with human factors and usability engineering, including IEC 62366‑1, formative and summative evaluations, use‑related risk analysis, and clinical‑use device readiness.
• Demonstrated expertise in risk‑management activities, including FMEAs, hazard analyses, and risk‑control verification.
• Working knowledge of connected and software‑enabled medical‑device development, including software verification and validation, cybersecurity risk management, software lifecycle oversight, software change control, and familiarity with IEC 62304.
• Experience working in a matrixed pharmaceutical, biotechnology, medical‑device, or digital‑health environment.
• Experience managing external technical partners, including development partners, suppliers, CROs, test laboratories, and contract manufacturers.
• Strong written, verbal, and presentation skills, with the ability to clearly communicate complex technical issues, development status, and product risks to technical and nontechnical stakeholders.
• Experience leading, mentoring, and developing engineers or technical staff.

Required Qualification

B.S or M.S in engineering or another relevant discipline and a minimum of 10 years of experience (8 years with M.S., 6 years with Ph.D.) working within a medical device development environment. Relevant industry experience in medical‑device, drug‑delivery, digital, and drug‑device combination‑product development.

Preferred Skills

• Advanced degree in a technical, scientific, engineering, or business discipline.
• Experience supporting clinical studies for investigational devices or drug‑device combination products.
• Experience supporting FDA combination‑product regulatory strategy and submissions, including IND, BLA, NDA, CTA, IMPD, MAA, or related filings.
• Experience with medical‑device software lifecycle processes, software validation, mobile and cloud‑service validation, and cybersecurity principles.
• Experience with electrically powered, battery‑operated, sensor‑enabled, or electronically controlled delivery systems.
• Familiarity with IEC 60601‑series standards.
• Experience developing patient‑facing, home‑use, or self‑administered delivery systems.
• Experience supporting global development programs and international regulatory submissions.

At Vertex

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision‑making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range

Pay Range: $172,200 - $258,400

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.

Benefits

• 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].

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 and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion‑dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. 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 IgA nephropathy, neuropathic pain, APOL1‑mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH‑dependent Cushing’s syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

We Believe Our Culture

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters 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 16 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 www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X. We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.