Medical Device Risk Management Jobs in Utah (NOW HIRING)

Description

 Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics.

We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

Job Summary

The Program Manager is responsible for leading medical device development programs within a dynamic, customer-focused environment.   This role drives cross-functional execution from concept through production, ensuring alignment with customer requirements, project objectives, and regulatory standards. 

The Program Manager partners with customers, commercial teams, and internal stakeholders to manage scope, schedule, cost, and risk, while ensuring successful product development and transfer into production. 

Job Responsibilities

Program Leadership & Execution 

• Manages programs within defined scope, schedule, and budget, ensuring alignment with business and customer objectives  
• Leads cross-functional teams through all phases of product development, from concept through commercialization  
• Coordinates project timelines, deliverables, and resources to ensure successful execution  
• Proactively manages program challenges to maintain timelines and deliverables 

Customer & Stakeholder Management 

• Serves as a primary point of contact for customers, ensuring clear communication and alignment throughout the program  
• Collaborates with customers, suppliers, and internal teams to drive successful outcomes  
• Aligns internal teams and customers through effective communication and expectation management  

Planning, Scope & Change Management 

• Tracks scope changes and supports change order management  
• Ensures alignment of  project objectives with customer and business needs 

Risk Management & Problem Solving 

• Identifies project risks and leads development and execution of mitigation plans  
• Applies structured problem-solving methods and root cause analysis to address issues 

Regulatory, Quality & Compliance 

• Ensures adherence to design control processes, including proper documentation (DHF) and stage-gate deliverables  
• Supports development, build, test, and validation activities in compliance with regulatory requirements  

Financial Management 

• Supports invoicing and financial tracking aligned with project milestones and schedules  
• Assists in developing and maintaining accurate project budgets and forecasts 

Communication & Reporting 

• Communicates project status, risks, and key updates to stakeholders in a clear and timely manner  

Team Leadership & Development 

• Provides guidance and coordination to cross-functional team members  
• May mentor or support development of junior team members  

Commercial Support 

• Supports commercial activities, including proposal development, cost estimation, and quoting  
• Leads quoting efforts and/or provides input to ensure accuracy and quick turnaround 

Continuous Improvement & Miscellaneous 

• Contributes to continuous improvement of project management processes and methodologies  
• Performs other duties as assigned in support of business and organizational objectives. 

Requirements

• Bachelor's degree in Engineering or related field or equivalent experience  
• 5-8 years of relevant experience in medical device or related industry 
• Experience managing or leading projects within product development environments 
• Strong understanding of medical device development processes, including verification, validation, and design transfer 
• Strong organizational, communication, and stakeholder management skills 
• Ability to manage multiple priorities with moderate supervision
• Experience with structured problem solving and root cause analysis  

Why Join Biomerics?

At Biomerics, you will be part of a collaborative and growth-oriented organization dedicated to improving lives through innovation and manufacturing excellence. We value individuals who are passionate about building strategic customer partnerships and driving operational and commercial success within the medical device industry. 

Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k.
 

The salary estimates are estimates from this job board and not a guarantee from Biomerics' salary range.

Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics, and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.