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What is the role of a Associate Director, Device Development at Jobgether?

The Associate Director, Device Development position at Jobgether is a Full-time or part-time position opportunity in the Executive/Management field.

Where is this Associate Director, Device Development job located?

United States, Other / Non-US, United States

What type of employment is offered for this Associate Director, Device Development role?

Full-time or part-time position

What is the expected salary for this Associate Director, Device Development job?

Compensation will be discussed during the hiring process.

Associate Director, Device Development job near me in United States, Other / Non-US at Jobgether

Associate Director, Device Development

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Device Development in the United States.

This is a high-impact opportunity for an experienced device development leader to help advance innovative biologic and combination product programs within a fast-growing biotechnology environment. The role focuses on leading the technical development of patient-centric drug delivery systems, including prefilled syringes, needle safety devices, and autoinjectors, while supporting products from clinical development through commercialization. Working within a highly collaborative and outsourced manufacturing model, you will partner closely with external suppliers, CMOs, CROs, and cross-functional internal teams to ensure the successful development, transfer, and manufacturing of high-quality combination products. This position is ideal for a technically strong professional who thrives in dynamic organizations, enjoys solving complex development challenges, and is passionate about improving patient outcomes through innovative delivery technologies. The role offers broad visibility, strategic influence, and the opportunity to contribute directly to cutting-edge therapeutic programs in a rapidly evolving biotech setting

Accountabilities:

Serve as the technical lead for cross-functional teams responsible for the design, development, and commercialization of biologic/device combination products.
Provide subject matter expertise for patient-centric delivery systems including prefilled syringes, autoinjectors, needle safety devices, and related technologies.
Develop and maintain product realization documentation such as user requirements specifications, design inputs, verification plans, validation protocols, and technical reports.
Oversee test method development, validation activities, design verification testing, and statistical analysis performed by external laboratories and manufacturing partners.
Lead human factors engineering strategies and coordinate formative and summative studies with specialized service providers to support design validation activities.
Collaborate with Quality teams to strengthen combination product quality systems and ensure compliance with applicable cGMP regulations and industry standards.
Support technology transfer, process validation, manufacturing oversight, and commercial readiness activities across external manufacturing sites and supply chain partners.
Review and approve manufacturing documentation, validation reports, batch records, investigations, and technical studies to ensure product quality and regulatory compliance.
Act as a technical SME during root cause investigations, deviation management, and risk assessments in accordance with ISO 14971 and related standards.
Contribute to regulatory submissions including INDs, IMPDs, BLAs, amendments, and other global filings while presenting technical findings to internal and external stakeholders.

Requirements:

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related technical discipline; advanced degree preferred.
Minimum of 10 years of relevant experience within biotechnology, pharmaceutical, medical device, or combination product development environments.
Hands-on experience developing biologic/device combination products, including prefilled syringes, autoinjectors, needle safety devices, or on-body injectors.
Strong expertise in design controls, user requirements, design verification and validation, process validation, and product transfer activities.
Solid understanding of regulatory requirements and industry standards related to combination products, including 21 CFR Part 4, 21 CFR 820, ISO 13485, and ISO 14971.
Experience working with CMOs, CROs, external device suppliers, and outsourced manufacturing operations.
Proven ability to execute root cause investigations, risk management activities, and data-driven technical analyses.
Excellent written and verbal communication skills with the ability to present technical concepts clearly across cross-functional teams and external partners.
Strong organizational, multitasking, and project leadership abilities in fast-paced and evolving environments.
Ability to travel up to 25%, including domestic and international travel to vendor and manufacturing sites.
Ability to work across multiple time zones and collaborate effectively within global teams.

Benefits:

Competitive salary range between $180,000 and $200,000 USD.
Performance bonus opportunities and equity grant participation.
Comprehensive medical, health, welfare, and retirement benefits package.
Generous paid time off including three weeks of PTO, paid sick leave, and two company-wide shutdown weeks annually.
Fully remote work flexibility within the United States.
Opportunity to contribute to a fast-paced and highly innovative biotechnology organization.
Strong culture focused on collaboration, professional growth, and continuous learning.
Access to development resources and opportunities for career advancement.
Regular in-person team meetings and collaborative events to strengthen relationships and drive innovation.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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Associate Director, Device Development in United States at Jobgether

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