Product Development Engineer, Dorado

Product Development Engineer

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mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.

Job Description:

We are seeking a results-driven and innovative R&D / Product Development Engineer to support the design and development of a new medical device from concept through commercialization. This position plays a key role in creating and improving product designs, conducting feasibility studies, prototyping, and ensuring compliance with industry regulations. The ideal candidate will collaborate with cross-functional teams including Quality, Regulatory Affairs, and Manufacturing to ensure that all development stages meet functional, safety, and regulatory standards.

Key Responsibilities:

Lead or support the development of new medical devices, including concept generation, design, prototyping, and testing.
Create and maintain design documentation in accordance with design control procedures (e.g., DHF, DMR, Risk Analysis, Design Inputs/Outputs).
Conduct feasibility studies and validation activities (e.g., verification/validation testing, biocompatibility, shelf-life, etc.).
Collaborate with cross-functional teams to ensure smooth transfer from development to manufacturing.
Ensure compliance with applicable regulations and standards (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
Participate in design reviews, technical reports, and regulatory submissions as needed.

Requirements:

Bachelor's degree in Biomedical, Mechanical, Electrical, or related Engineering field.
2+ years of experience in product development, preferably in the medical device industry.
Knowledge of design controls and regulatory requirements for medical devices.
Experience with CAD tools and engineering documentation.
Strong problem-solving skills, analytical thinking, and attention to detail.
Excellent communication skills and ability to work in cross-functional teams.
English fluency (written and spoken) is required.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

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Location:: Dorado