The PositionArrowhead Pharmaceuticals is seeking a highly skilled and experienced Engineer to support device and combination product development. This role will provide technical leadership for the strategy, development, and execution of drug-device combination product programs from early concept through commercialization and lifecycle management.
The successful candidate will bring deep expertise in drug delivery systems, human factors engineering, design controls, risk management, and medical device regulations, with demonstrated experience developing prefilled syringes and autoinjectors. This individual will partner closely with cross-functional teams, including Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, and Regulatory Affairs, to ensure combination products are developed in accordance with applicable regulatory requirements and meet patient needs.
The ideal candidate is a collaborative and highly organized technical leader who can manage multiple priorities, communicate complex information effectively, and influence internal and external stakeholders.
Responsibilities
- Develop and execute strategies and technical roadmaps for drug-device combination product development aligned with program and company objectives.
- Provide technical leadership for combination product development from concept through commercialization and lifecycle management.
- Lead human factors and usability engineering activities to support safe and effective product use.
- Author and review human factors/usability engineering plans, usability risk assessments (URRAs), study protocols and reports, and supporting design control documentation.
- Lead and support formative and summative human factors evaluations, including study oversight and interpretation of results.
- Provide technical expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing processes.
- Lead development activities for prefilled syringes, autoinjectors, and other drug delivery systems.
- Collaborate cross-functionally with Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, and Regulatory Affairs to support successful program execution.
- Oversee external testing laboratories supporting device characterization, design verification, and other development activities, including authoring and reviewing protocols and reports.
- Establish, implement, and maintain design control processes and associated Design History File (DHF) documentation.
- Support design transfer activities, including process risk assessments, process specifications, control strategies, and statistical evaluation of specifications.
- Author and review relevant combination product sections of regulatory submissions, including INDs, IMPDs, BLAs, and MAAs.
- Ensure compliance with applicable FDA and EU medical device and combination product regulations and industry standards, including ISO 14971, ISO 13485, and EU MDR.
- Identify technical and program risks, develop mitigation strategies, and communicate issues and recommendations to key stakeholders.
- Manage external vendors and development partners, including project deliverables, timelines, and contracts.
- Manage multiple projects and priorities while maintaining alignment with program timelines and budgets.
- Build and maintain effective relationships with internal stakeholders, external partners, vendors, and testing laboratories.
- Support continuous improvement of device development processes, procedures, and capabilities.
Requirements- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or a related scientific or engineering discipline.
- 8+ years of relevant experience in combination product or medical device development, including experience supporting products from initial concept through commercialization and lifecycle management.
- Demonstrated experience developing and commercializing prefilled syringes and autoinjectors.
- Strong knowledge of subcutaneous drug delivery systems, device design, systems engineering, materials, and manufacturing processes.
- Demonstrated experience implementing and managing design controls and risk management processes.
- Experience leading human factors and usability engineering activities, including formative and summative evaluations, usability risk assessments, and preparation of plans, protocols, and reports.
- In-depth knowledge of applicable FDA and EU medical device and combination product regulations, quality systems, and industry standards, including ISO 14971, ISO 13485, and EU MDR.
- Experience overseeing device characterization and design verification testing.
- Experience authoring or contributing to device-related sections of regulatory submissions.
- Proven experience managing external vendors and development partners.
- Excellent written and verbal communication skills with the ability to communicate complex technical information to a variety of audiences.
- Demonstrated ability to influence and collaborate effectively across functions and with external partners.
- Strong organizational and project management skills with the ability to manage multiple priorities in a fast-paced environment.
Preferred- Advanced degree in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or a related field.
- Experience with biological drug products and primary packaging development.
- Experience with cGMP process development, manufacturing controls, process risk assessments, and design transfer.
- Experience working in a fast-paced or high-growth biotechnology/pharmaceutical environment.
- Demonstrated experience mentoring or providing technical leadership to other engineers and scientists
Wisconsin pay range
$120,000-$145,000 USD
California pay range
$135,000-$1,550,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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