Associate Director – Device Development

Apogee Therapeutics

Associate Director leading the development of biologic/device combination products at Apogee Therapeutics. Collaborating with cross-functional teams to ensure high quality and regulatory compliance.

Posted 5/22/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $180,000 - $200,000 per yearWebsite

About the role

Key responsibilities & impact

Technical lead on cross-functional teams responsible for development of combination products
Work with Quality function to develop and refine the combination product quality management system
Author product-specific Product Realization documentation, including User Requirements Specifications, Design and Development Inputs, and Design and Development Verification plans, protocols, and reports
Oversee test method development, test method validation and design verification at external labs
Establish human factors strategies and work with human factors service vendors to execute formative and summative HF studies for Design and Development Validation
Work with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to meet development, manufacturing, and supply goals
Review and approve manufacturing protocols, master and executed batch records, validation plans and reports, and other cGMP documents
Support person-in-plant during manufacturing at CMOs, as needed
Serve as technical SME in root cause analysis and deviation investigations
Author, review, and approve development studies and technical reports
Collaborate effectively with cross-functional teams, including analytical development, supply chain, quality assurance, and regulatory affairs
Serve as technical SME on due diligence and business development opportunities
Communicate findings and progress through presentations and reports
Author and support regulatory submissions (IND, IMPD, amendments, BLA, etc.)

Requirements

What you’ll need

Minimum 10 years of relevant industry experience, BS in mechanical engineering, biomedical engineering, chemical engineering or a related field required, advanced degree a plus
Must have hands-on experience in developing biologic/device combination products, specifically with prefilled syringe with needle safety device, autoinjector, and/or on-body injector. Experience should include:
Development of User Requirements and Design Input Requirements
Establishing statistical acceptance criteria based on reliability and confidence intervals
Statistical analysis of test data
Test Method Validation
Design and Development Verification plans, protocols, and reports
Design and Development Validation and Design and Development Transfer
Process Validation
Experience in late phase clinical development and commercialization of combination products
Must have sound understanding of current regulatory requirements and industry standards for biologic/device combination products, including 21 CFR Part 4, 21CFR820.10/ISO 13485
Experience working with external device suppliers, CMOs and cGMP manufacturing facilities
Experience performing risk management per ISO 14971
Experience with execution of root cause analysis and investigations
Strong communication and presentation skills
Availability to participate in calls across multiple international time zones
Ability to travel up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year as well as domestically and internationally to vendor / CDMO sites
Ability to work independently and multi-task in a fast-moving organization
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Benefits

Comp & perks

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

ATS Keywords

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Hard Skills & Tools

biologic/device combination productsprefilled syringeautoinjectoron-body injectorUser RequirementsDesign Input Requirementsstatistical analysisTest Method ValidationDesign and Development VerificationProcess Validation

Soft Skills

communication skillspresentation skillsability to work independentlymulti-taskingcollaborationroot cause analysisdeviation investigationstechnical subject matter expertiseproblem-solvingadaptability