Full Job Description Position Summary:

The Biomedical Engineer will support the development, maintenance, and regulatory compliance of OPM's medical devices. This role combines engineering and quality/compliance responsibilities to ensure devices meet performance, safety, and regulatory standards throughout the product lifecycle. This position offers the opportunity to gain hands-on experience across both technical engineering functions and regulatory compliance processes, while collaborating with cross-functional teams including Quality, Design, and Manufacturing. The ideal candidate demonstrates strong critical thinking capabilities, exercises independent judgment while maintaining rigorous attention to detail, utilizes data-informed analysis to support continuous engineering and compliance improvements, and is motivated to grow within the medical device industry.

Responsibilities:

Manage case documentation, design controls, and compliance activities for custom medical devices across multiple regulatory markets. Conduct design reviews, analyze custom device trends, and collect data for performance metrics. Develop well-structured Technical Memos to support design controls, compliance activities, and cross-functional decision-making. Oversee Post-Market Clinical Follow-Up (PMCF), customer feedback, and author regulatory reports including periodic safety update reports (PSURs). Support Engineering Change Orders (ECOs) and implement continuous improvements in safety, quality, and scrap reduction. Support and execute engineering studies, including development of study plans and coordination of test activities. Author test protocols and technical reports to document study objectives, methodologies, results, and conclusions. Support annual FMEA reviews and perform root cause analysis for complaints and nonconformance investigations. Maintain and update QMS documentation, including revisions, redlines, and procedure updates. Collaborate cross-functionally to ensure engineering and compliance solutions meet regulatory and quality standards.

Secondary Job Functions:

Assist with verification and validation (V&V) activities to ensure product performance and compliance with design and regulatory requirements. Support Corrective and Preventive Action (CAPA) activities, including investigation, root cause analysis, and implementation of corrective actions. Provide support for preparation and maintenance of regulatory documentation as required. Provide Engineering and Compliance support for other product lines as needed. Collaborate with cross-functional teams to ensure testing and documentation activities align with quality system and regulatory standards. Performs other related duties as assigned by manager.

Requirements:

Bachelor's degree in Engineering, Science, or related discipline (Biomedical Engineering preferred). Understanding of human anatomy and physiology to support design, compliance, and clinical assessment activities. Minimum of 1-3 years of experience in a regulated medical device environment (ISO 13485, FDA, or equivalent), or equivalent professional experience. Excellent verbal and written communication skills. Demonstrated ability to manage multiple priorities in a fast-paced, regulated environment. Strong organizational skills with the ability to work independently and meet deadlines. Proficiency in data analysis tools (e.g., Excel, MiniTab) as well as CAD software/SOLIDWORKS; must know how to use Microsoft Suite (e.g., Excel, Word, PowerPoint)

Pay:

$65,000.00 - $75,000.00 per year

Benefits:

401(k) Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Vision insurance

Work Location:

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