Department: R&D
Reports to: Chief Operating Officer
Location: On Site – Miramar, FL
Employment Type: Full-time
Position Summary
Join a fast-paced startup developing an innovative, single-use sterile medical device and a reusable peripheral console. The ideal candidate is self-directed and flexible, supporting the full product lifecycle – from design, prototyping, and requirements definition through verification, validation, and production support – and driving product quality, reliability, and continuous improvement.
Key Responsibilities
- Define, document, and manage product requirements and specifications using systems engineering principles, ensuring traceability from user needs through design outputs.
- Author and execute design verifications and validations (V&V), test method validations (TMV), process validations (PV), and equipment qualifications (IQ/OQ).
- Drive process improvement initiatives to enhance product quality, manufacturability, and development efficiency.
- Create, update, and review design and process documentation including engineering drawings (and CAD models), work instructions, test methods, process records, and work orders.
- Lead investigations into product and process issues, including nonconformances and CAPA, performing root cause analysis and implementing effective corrective actions.
- Apply structured problem-solving methodologies (e.g., 8D, DMAIC, fishbone, 5 Whys) to resolve technical challenges.
- Plan, conduct, and oversee prototyping and characterization testing; analyze results and document findings in clear, defensible technical reports.
- Collaborate cross-functionally with Operations, Quality, Manufacturing, and Supply Chain throughout the product lifecycle.
Required Qualifications
- Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering discipline.
- Minimum 5 years of product development engineering experience in medical device preferred.
- Demonstrated experience with Design Controls (21 CFR Part 820 / QMSR) and systems engineering practices (requirements and specification development, traceability).
- Proven experience writing and executing V&V protocols and conducting product testing.
- Proficiency in CAD software (SolidWorks) and engineering drawings.
- Hands-on experience with nonconformance handling, CAPA, and root cause investigation.
- Demonstrated application of structured problem-solving and process improvement methods.
- Familiarity with relevant standards (e.g. ISO 13485, ISO 14971, ISO 10993, ISO 11135, IEC 60601) preferred.
- Lean / Six Sigma certification (Green Belt or Black Belt) preferred.
Competencies
- Strong analytical and critical-thinking skills.
- Excellent written and verbal (English) communication.
- Ability to manage multiple priorities and drive projects to completio.
- Collaborative, cross-functional team player with leadership presence.
Please send resume to [email protected]
Contact us at (954) 578-3153
We are an equal opportunity employer.
Pay: $85,000.00 - $110,000.00 per year
Benefits:
- Health insurance
- Paid time off
Work Location: In person
