Senior Product Development Engineer

Prometheus Therapeutics Inc. offers a collaborative, fast-paced environment in a medical device startup, supporting the full product lifecycle from design through production with a focus on quality and continuous improvement. This onsite role in Miramar, FL provides a salary range of USD 85,000 to 110,000 per year and benefits including health insurance and paid time off.

Benefits

• Health insurance
• Paid time off

Responsibilities

• Define, document, and oversee product requirements and specifications using systems engineering methods, ensuring full traceability from user needs to design outputs.
• Create and perform design verifications and validations (V&V), test method validations (TMV), process validations (PV), and equipment qualifications (IQ/OQ).
• Lead process improvement efforts to boost product quality, manufacturability, and development efficiency.
• Develop, revise, and review design and process documentation such as engineering drawings (and CAD models), work instructions, test methods, process records, and work orders.
• Head investigations of product and process issues, including nonconformances and CAPA, conducting root cause analysis and implementing effective corrective actions.
• Apply structured problem-solving approaches (for example 8D, DMAIC, fishbone diagrams, and 5 Whys) to address technical challenges.
• Plan, perform, and supervise prototyping and characterization testing; analyze results and document findings in clear, technically defensible reports.
• Collaborate across functions with Operations, Quality, Manufacturing, and Supply Chain throughout the product lifecycle.

Requirements

• Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering discipline.
• Minimum 5 years of product development engineering experience, preferably in medical devices.
• Experience applying Design Controls (21 CFR Part 820 / QMSR) and systems engineering practices, including requirements and specifications development with traceability.
• Proven track record creating and executing V&V protocols and performing product testing.
• Proficiency with CAD software (SolidWorks) and producing engineering drawings.
• Hands-on experience handling nonconformances, CAPA, and root cause investigations.
• Demonstrated use of structured problem-solving and process improvement methods.
• Familiarity with standards such as ISO 13485, ISO 14971, ISO 10993, ISO 11135, and IEC 60601 is preferred.
• Lean Six Sigma Green Belt or Black Belt certification is preferred.

Technologies

• SolidWorks

Competencies

• Strong analytical and critical-thinking skills
• Excellent written and verbal communication in English
• Ability to manage multiple priorities and drive projects to completion
• Collaborative, cross-functional team player with leadership presence