Sr. Engineer

Job Type

Full-time

Description

Company Overview

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 Senior Project Engineer is responsible for leading cross-functional engineering projects that support the development and transfer of medical devices in a regulated manufacturing environment. They serve as a technical and execution leader for new product introductions, process improvements, equipment implementation, and lifecycle engineering activities, ensuring projects are delivered on time, within scope, and in compliance with applicable requirements.

Job Responsibilities

• Lead the design and development of medical devices, implants, or instruments. Apply Design for Manufacturing (DFM) principles to ensure products can be scaled efficiently and cost-effectively Author and maintain FDA-compliant Design History Files (DHF) and ensure full compliance with FDA 21 CFR Part 820, cGMP, and ISO 13485.
• Lead the execution of manufacturing process qualifications and validations (IQ/OQ/PQ) for tooling, automation, and production equipment.
• Develop project plans, manage budgets, track timelines, and coordinate tasks across R&D, Quality, Manufacturing, and Supply Chain.
• Troubleshoot manufacturing issues, lead root-cause analyses, and implement corrective and preventive actions (CAPA) to improve product yield and minimize waste.
• Partner with marketing, manufacturing, and external suppliers to manage design transfers and ensure successful product launches.
• Own and drive multiple engineering projects simultaneously from initiation through completion, ensuring designs are manufacturable, scalable, cost-effective, and compliant with applicable regulatory, quality, and customer requirements.
  
  

Requirements

Education / Certifications

• Bachelor’s degree in Mechanical, Biomedical, Chemical, or Industrial Engineering (Master's or PMP Certification preferred).
  
  

Job Requirements

• 5 to 8 years of engineering and project management experience within the medical device, pharmaceutical, or highly regulated manufacturing industry.
• Deep understanding of cGMP, Design Controls, and FDA regulations.
• Direct experience supporting New Product Introduction (NPI), process development, manufacturing transfer, and production scale-up activities.
• Experience drafting, executing, and maintaining engineering protocols, technical reports, validation documentation, and related project deliverables.
• Proficiency with common engineering, statistical analysis, collaboration, and project management tools, including SolidWorks, MS Project, Excel, Teams, Minitab, or similar platforms.
• Strong project management, organization, communication, and stakeholder coordination skills, with the ability to manage priorities across multiple concurrent initiatives.
• Strong technical and mechanical aptitude, including the ability to evaluate designs, troubleshoot manufacturing challenges, and develop practical engineering solutions.
  
  

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

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.