Are you passionate about creating innovative medical and drug delivery devices that positively impact lives? Join our dynamic team at Gilero, where we're committed to developing solutions that enhance patient outcomes. As a Senior Product Development Engineer, you will lead the design, development, and production processes of medical devices and combination products. Your focus will be on idea generation, verification, validation, and the development of Design History Files (DHF) that meet state-of-the-art requirements.
If you excel in fast-paced, collaborative environments and are dedicated to achieving high-quality results while engaging with customers, vendors, and internal teams, we want you on our team. Become a part of a company that values integrity, innovation, and excellence!
Key Responsibilities :
- Serve as a technical lead, enhancing the rigor of product development with oversight on complex projects and cross-functional initiatives.
- Manage intricate product development deliverables from conception to manufacturing transfer.
- Identify and track technical risks, providing valuable engineering insights.
- Mentor junior engineers and provide critical feedback.
- Guide the development team in tackling technical risks effectively.
- Create, review, and release documentation aligning with Gilero's Quality Management System (QMS) and project lifecycle.
- Support project managers with technical project insights for accurate budgeting and feasibility analysis.
- Act as project manager for smaller, technically focused initiatives.
Skills and Qualifications :
Bachelor's degree in Engineering or a related technical field.Over 5 years of experience in product development within the medical device or combination product space.Expert at converting complex situations into clear project deliverables.Adept in leading teams to meet challenging objectives through structured simplification.Solid understanding of Good Development Practices (GDP) and the Phase Gate System.Extensive knowledge of ISO 14971, ISO 13485, CFR 21, and ISO 10993.Ability to translate Voice of Customer (VOC) feedback into actionable design criteria.Experience in drafting clinically relevant User Requirements with minimal oversight.Capability to transform User Needs into measurable technical specifications.Proficient in statistical analysis and interpretation of test data.Experience with risk documentation, risk analysis, and leading product risk assessments.Strong background in developing and validating test methods.Skilled in executing design verification and validation protocols.Familiarity with technical drawings and GD&T interpretation.Ability to understand and adhere to technical standards (ISO, ASTM, IEC).Personal Attributes :
Embody our core values of collaboration, integrity, innovation, and excellence.Thrives in a fast-paced, entrepreneurial environment.Self-motivated with a desire for career advancement and responsibility.Deep commitment to delivering quality service to both internal and external customers.Excellent oral and written communication skills.Why Join Gilero?
Founded in 2002, Gilero, as part of the Sanner Group, is committed to designing, developing, and manufacturing groundbreaking medical devices and drug delivery products. We are proud of our collaborative culture that reflects our values of integrity, innovation, excellence, and teamwork. Our rapid growth continues to shape our purpose of improving patient outcomes. Our US locations include Carlsbad, CA; Chicago, IL; Raleigh, Durham, Greensboro, and Pittsboro, NC.
Enjoy competitive benefits including an annual bonus plan, multiple health insurance options from BCBS, dental and vision coverage, life insurance, short-term and long-term disability, a matched 401(k) plan with zero vesting period, and access to LinkedIn Learning for ongoing personal and professional development.