Engineer Jobs in Miramar, FL

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1mo ago

Senior Product Development Engineer

PROMETHEUS THERAPEUTICS INC. Miramar, FL

Miramar, FL

1mo ago Closed

$85k - $110k/yr Full time Senior Design Design Engineering

This position is no longer accepting applications (closed Jul 25, 2026).

Job Description

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

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