Arrowhead Pharmaceuticals, Inc.-posted about 1 month ago
Full-time • Manager
Verona, WI
501-1,000 employees
Professional, Scientific, and Technical Services

The Associate Director, Device Engineering is a detail-oriented and results-driven individual with a strong understanding of product design, pharmaceutical device regulations, GMP standards and workload management. This individual is responsible for driving commercial readiness and managing the life cycle of drug device combination products. This role will work closely with Global Operations, Development, Quality, Procurement, Regulatory, Packaging Engineering, consultants and outside vendors.

  • Develop and oversee design control system and business strategies to support commercial device/combination drug development.
  • Create and execute project plans and schedules.
  • Develop, execute, and manage documents for product design, specifications, development plans, characterization plans, verification/validation plans, risk management, human factors and other related product development documents.
  • Author or Review/Approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
  • Participate in design reviews, provide critical design for manufacturing input to ensure product designs are robust for manufacturing.
  • Support site and vendor risk assessments, develop and maintain pFMEAs, and develop control plans to mitigate risks. Ensure that all product functional requirements are translated into manufacturing requirements and process controls.
  • Provide technical support for CMO/vendor sourcing activities.
  • Sponsor and/or lead projects, initiatives, and process improvements falling under device engineering business systems scope to build for the future.
  • Bachelor's Degree in Engineering or other field related to the essential duties of this role and 10+ years of increasing responsibility in medical device industry, focused on engineering processes and procedures. (or a Master's Degree with 8+ years of experience, or a Doctorate Degree with 5+ years of experience.)
  • Strong MS Office skills (Outlook, Excel, PowerPoint, and Word)
  • Excellent verbal and written communication skills
  • A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead
  • Ability to work prolonged periods at a desk and working on a computer.
  • Aptitude for independently resolving competing priorities in a fast-paced environment
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Experience with product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.
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