Senior Process Engineer

Senior Process Engineer

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 the 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' and patients' lives that depend on our products.

Biomerics values 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 and our team members.

The Senior Process Engineer will be responsible for supporting and improving the manufacturing of class II medical and surgical devices 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 to those specifications. All activities must be documented according to design control requirements in a design history file (DHF).

The Senior Process Engineer may be an individual contributor in a small cross-functional team comprising 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, then lead the transfer of the products to production and ensure a smooth transition to the production engineering team.

Responsibilities:

• 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 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 reoccurrence of non-conformities related to the product, service, processes, or 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:

• MS in Engineering or other relevant Discipline + 3 years' experience or BS in engineering or other relevant Discipline + 5 years experience (preferably in the medical device field (Preferred) or manufacturing industry.
• The ability to influence a team toward business objectives (Required).
• Must function with little or no supervision (Required).
• Experience working through all aspects of medical device design & development, including design verification and validation, process validation, and technology transfer (Preferred).
• A Six Sigma Green/Black Belt (Preferred)
• The ability to perform statistical analysis using k-factors, Ppk, DOEs, and root cause analysis (Preferred).
• Proficiency in solid 3-D modeling (i.e., SolidWorks) (Preferred).
• Design for manufacturability and assembly (DFMA) (Preferred).
• 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).
• Ability to write manufacturing work instructions that operators can follow.
• Lead a team of engineers and/or techs supporting all aspects of manufacturing.

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k, and On-site Fitness Facility.

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

Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted). Biomerics only accepts non-solicited resumes or candidate submittals from search/recruiting agencies 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.