Related skills
cgmp prefilled_syringe needle_safety_device autoinjector📋 Description
- Lead cross-functional teams in development of biologic/device combo products.
- Partner with Quality to refine the combo product quality management system.
- Author URS, Design Inputs, and verification plans.
- Oversee test method development and validation at external labs.
- Establish human factors strategies and HF studies.
- Work with CMOs/CROs to meet development, manufacturing, and supply goals.
🎯 Requirements
- 10+ years of relevant industry experience.
- BS in mechanical/biomedical/chemical engineering; advanced degree a plus.
- Hands-on biologic/device combo product development (prefilled syringe, autoinjector).
- D&D docs: URS, Design Inputs, and V&V plans.
- Regulatory knowledge: 21 CFR Part 4, ISO 13485.
- Experience with CMOs/CROs and external device suppliers.
🎁 Benefits
- Culture grounded in CORE values: Caring, Original, Resilient, Egoless.
- Fast-paced environment with opportunities to wear multiple hats.
- Competitive compensation with base pay, bonus, equity, health and retirement.
- Three weeks PTO, two company shutdowns, paid sick leave.
- Commitment to professional growth and development resources.
- Regular all-team in-person meetings to build relationships.
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