Vertex Pharmaceuticals

Vertex Pharmaceuticals

Medical Device & Combination Product Development, Associate Director

Boston, MA · Director

Sponsorship not specified$172k-$258kDetected 6 hours ago
CybersecurityRecruitingClinical TrialsFDA RegulatoryMedical DevicesLeadershipMentoringRegulatory Affairs

Stay score

odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

Personalize to your clock →

H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level IV · 4×
Level I$56,4931 entry
Level II$71,6352 entries
Level III$86,7573 entries
Level IV$101,8994 entries

This range already reaches Level IV — the maximum four lottery entries.

DOL prevailing wage, 2026-27 wage year · Fundraisers (13-1131) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.

Employer immigration record

from this employer's Department of Labor filings

Green-card follow-through: 83%

Of 12 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 515 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

29 transfer filings in the last year, covering 29 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

Community outcomes

No reports yet — be the first to help the next applicant.

About the role

  • 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.
  • Provide technical leadership for device architecture, delivery performance, connectivity, user interfaces, and accessories.
  • Apply risk-management principles in accordance with ISO 14971, including hazard analyses, FMEAs, use-related risk analyses, risk controls, and benefit-risk assessments.

Responsibilities

  • Lead device and combination-product development activities from early feasibility through clinical development and commercialization readiness.
  • 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.
  • 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.
  • 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.
  • Translate intended use, clinical requirements, and user needs into clear system, software, interface, and component design inputs.

Requirements

  • Experience with human factors and usability engineering, including IEC 62366-1, formative and summative evaluations, use-related risk analysis, and clinical-use device readiness.

Skills

  • Strong knowledge of drug-device system architecture and requirements engineering.
  • Experience in mechanical and electromechanical device development.
  • Demonstrated expertise in risk-management activities, including FMEAs, hazard analyses, and risk-control verification.
  • Experience working in a matrixed pharmaceutical, biotechnology, medical-device, or digital-health environment.
  • Required Qualification
  • 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 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.

Compensation

  • $172,200 - $258,400
  • 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.

Company info

  • At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.

Equal opportunity

  • 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 ApplicationAssistance@vrtx.com
Apply directly at Vertex Pharmaceuticals →Create a free account for alerts like thisView Vertex Pharmaceuticals immigration profile

This listing is sourced directly from Vertex Pharmaceuticals's careers page and normalized into a canonical job model.