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JOB TITLE:

R&D Engineer II

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. 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, and excellence, and we care. Our team-oriented, customer-focused corporate culture places a premium on building

JOB DESCRIPTION:

As an R&D II Engineer, you design and develop various catheters for new business contracts. You prepare catheter design concepts and conduct engineering design reviews.

JOB RESPONSIBILITIES:

• Contribute to design, development, and validation activities through product life cycle for development products in accordance with the project scope.
• Participate in brainstorming sessions to identify creative ideas and unique solutions.
• Execute deliverables for the Design Control process to deliver the desired product to production in a cost-effective manner while hitting product performance and?profitability goals.
• Complete and manage Design History File(s), Design Controls, Design Verification & Validation, and all necessary activities in accordance with all internal and external processes, procedures, and standards (MDR, ISO, EN, etc.).
• Read and understand customer specifications/requirements to translate them into clear, concise performance and functional requirements.
• Conduct engineering evaluation, characterization, design of experiments (DOE), bench testing, or other verification activities to improve and confirm capability in the design and process.
• Use risk assessment tools such as FMEA, root cause analysis, etc. throughout the product development lifecycle.
• Work with development technicians/operators to perform hands-on prototyping or testing.
• Provide directions and instructions to development/production operators and technicians on new and revised processes.
• Assist with new tooling/fixturing, procurement, installation, qualification, documentation, and training.
• Demonstrate and utilize tried and true engineering methods and resources to streamline the development process.? Evaluate new technologies and ideas for new products.
• Use statistical tools to analyze data, make development decisions, and improve process capability (Six Sigma, SPC, DOE)
• Develop manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
• Other duties may be assigned as required.

• Bachelor’s Degree in Engineering is highly desired, or a combination of work history in the medical device field.
• 4+ years of medical device (preferred) or manufacturing experience.
• Familiarity with design controls, process development, and characterization of test methods for selection, verification, and validation of components, sub-systems, and assemblies.
• 3D modeling (SolidWorks preferred) and working knowledge of drafting specifications such as GD&T.
• Experience in a regulated environment and demonstrated competence in required documentation and industry-accepted practices such as Good Manufacturing Practices (GMP), ISO 13485 Design Control, and Quality Systems Regulation (QSR).
• Complex problem-solving skills (e.g., use of statistical techniques such as the design of experiments (DOE), Analysis of Variance (ANOVA), t-tests, normality, and process capability metrics in decision-making).
• Excellent technical writing skills.
• Strong communication, presentation, follow-through, and organizational skills. Proven ability to work effectively with coworkers at all levels of the organization.

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

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 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 and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.