Design Transfer Engineer II

Apply 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 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 the lives of our employees and the patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care.

Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

Job Description

The Design Transfer Engineer II will design and manufacture the transfer of class II medical and surgical devices in a dynamic, customer-focused organization.

The Design Transfer Engineer II will be expected to work with customers to understand product and process specifications, develop and transfer manufacturing processes, and build and test devices to those specifications.

All activities will be expected to be documented according to design control requirements in a design history file (DHF).

The Design Transfer Engineer II 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.

The Design Transfer Engineer II will work within budget, schedule, and scope constraints while managing risk and ensuring adherence to established processes & regulations.

The Design Transfer Engineer II may be an individual contributor and lead a small cross-functional team of engineering, operations, and quality members to provide process and manufacturability input to designs throughout the product development process.

Job Roles and Responsibilities

• Interact with customers during the quoting and project execution processes.
• Provide engineering services in a phased development approach to develop & launch medical devices.
• Provide manufacturability & DFMEA input during the product development process.
• Provide test method & test method validation input for design verification and process validation activities.
• Work directly with suppliers to establish material sourcing.
• Develop manufacturing processes for medical devices and create associated PFMEAs.
• Design machines, tooling, and fixtures for manufacturing processes and flow.
• Develop and improve manual, semi-automated, or automated assembly processes & flow.
• Author and execute process validation activities.
• Use project management principles to create timelines, manage risk, work within budget and scope constraints, and ensure adherence to established processes and regulations.
• Support and troubleshoot equipment, programs, and processes already in production.
• Respond to customer complaints and initiate action to prevent the reoccurrence of nonconformities related to the product, service, processes, or quality system.
• 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.

Requirements

• A bachelor’s degree in engineering or a related field (mechanical, biomedical, chemical) is required). (Required).
• At least 2+ years of related work experience in the medical device field. (Required).
• Design for manufacturability and assembly (DFMA). (Required).
• Experience working through all aspects of medical device design and development, including design verification and validation, process validation, and technology transfer (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 (Preferred).
• Proficient in solid 3-D modeling (e.g., SolidWorks). (Preferred).
• The ability to function with little or no supervision. (Preferred).
• Strong communication skills & the capability to train others (Preferred).
• The ability to lead a team toward business objectives. (Preferred).
• A Six Sigma Green / Black Belt. (Preferred).
• Ability to perform statistical analysis using k-factors, Ppk, and DOEs, along with root-cause analysis (Preferred).

Biomerics offers the following benefits : Medical / Dental / Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 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 from Biomerics salary range.

Biomerics does not accept 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.