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Process Engineer, Extrusion

Biomerics
Salt Lake, UT Full Time
POSTED ON 2/24/2025
AVAILABLE BEFORE 5/25/2025

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 the design, development, and production of 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. 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 that depend on our products.

At Biomerics we believe in integrity, partnership, empowerment & accountability, trust, agility, teamwork, excellence, and we care. Our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships with customers as well as our team members.

Job Description :

The Process Engineer will be responsible for supporting and improving the manufacturing of medical and surgical devices and components in a dynamic, customer-focused organization. You will be expected to work with customers to understand product and process specifications, develop manufacturing processes, and build and test devices and components to those specifications. All activities will be expected to be documented according to design control requirements in a design history file (DHF).

The Process Engineer may function as an individual contributor in a small cross-functional team comprised of engineering, operations, and quality members to provide process and manufacturability input to designs throughout the product development process. You will support verification, validation, and regulatory submissions of these devices and components, then lead the transfer of the products to production and ensure a smooth transition to the production engineering team.

Requirements

  • Develop and improve manufacturing processes for new and existing products.
  • Support and troubleshoot equipment, programs, and processes already in production.
  • Design machines, tooling, and fixtures for new and existing products.
  • Author and execute process validation protocols, reports and other associated activities.
  • Develop the manufacturing processes and flow to meet product cost targets.
  • Provide manufacturability input to product development engineers during the product development process.
  • Respond to customer complaints and initiate action to prevent the recurrence of non-conformities related to the product, service, processes, or the quality system.
  • Demonstrating knowledge of project management principles.
  • Implement continuous improvement actions in conjunction with the Production Engineering team to ramp up the production of new products to meet customer demand curves and cost targets.
  • Lead a team of engineers and / or techs focused on supporting manufacturing.

Requirements

  • 5 years of experience. Engineering Degree is needed, mechanical engineer preferred.
  • Experience in the medical field (Preferred) or manufacturing industry.
  • The ability to influence a team toward business objectives (Required).
  • Must be able to function with little or no supervision (Required).
  • The ability to perform statistical analysis using k-factors, Ppk, Mintab, and DOEs along with root cause analysis (Required).
  • Proficient with medical process validation, including (IQ, OQ, PQ), test method definition, root cause analysis, test method validations, measurement systems analysis (MSA), root cause analysis, and structured problem solving (Required).
  • Experience working through all aspects of medical device design & development including design verification and validation, process validation, and technology transfer (Preferred).
  • Proficiency in solid 3-D modeling (i.e. SolidWorks) (Preferred).
  • Design for manufacturability and assembly (DFMA) (Preferred).
  • Ability to write manufacturing work instructions that operators are able to follow.
  • Lead a team of engineers and / or techs supporting all aspects of manufacturing.
  • A Six Sigma Green / Black Belt (Preferred).
  • Biomerics offers the following benefits : Medical / Dental / Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k, Onsite Fitness Facility

    Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).

    The salary estimates are estimates from this job board and not a guarantee of 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. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.

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