R&D Engineer II

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 more than just a company; we are a community. We value our diverse employee base and understand that a strong, skilled, and engaged workforce is the foundation of our continued success. We strive to live up to Biomerics' values in all our interactions. Joining our collective team means being part of a collaborative environment where your contributions are valued and can make a real difference in the lives of our employees and patients who depend on our products.

At Biomerics, we believe in more than just making great products. We believe in integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. These values are not just words on a page but the guiding principles of our team-oriented, customer-focused corporate culture. We place a premium on building strategic, mutually beneficial partnerships with customers and our team members. If these values resonate with you, we would be delighted to hear from you and discuss how your skills and experience could contribute to our mission.

Job Description

The R&D II Engineer will play a pivotal role in designing and developing catheters from concept to production that meet and exceed customer expectations, contributing significantly to our continued success.

Job Responsibilities

Execute design, development, and validation activities throughout the product life cycle for development products in accordance with the project scope (we Need to add information about what we design).Execute deliverables utilizing the Design Control process to create a cost-effective and efficiently manufacturable product. Contribute to deliverables utilizing the Design Control process in accordance with MDR, ISO, and EN standards.Understand customer specifications/requirements and translate them into precise, concise performance and functional requirements.Create and conduct engineering evaluation, characterization, design of experiments (DOE), bench testing, or other verification activities to improve and confirm capability in the design and process. Train and guide development technicians/operators to perform hands-on prototyping, testing, and process development. Execute document change requests and be able to effectively train development/production operators and technicians to update documentation. Conduct new tooling/fixturing design, procurement, installation, qualification, documentation, and training. Evaluate and implement new technologies and ideas for products.Use statistical tools to analyze data and make development decisions to improve process capability.Efficiently develop/refine manufacturing procedures and test/inspection plans to ensure quality requirements are met, and manufacturing process risks are mitigated.

Requirements

Preferred Bachelor’s Degree in Engineering with 2-5 years of medical device experience or a combination of work history in the medical device or relevant field totaling 5-8 years.Good understanding of design controls, process development, and characterization of test methods for selecting, verifying, and validating components, sub-systems, and assemblies. Efficient in 3D modeling (SolidWorks preferred) and working knowledge of drafting specifications such as GD&T. Complex problem-solving skills (e.g., using statistical techniques such as the design of experiments (DOE), Analysis of Variance (ANOVA), t-tests, normality, and process capability metrics in decision-making). Strong technical writing skills.Strong internal and external 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, 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.