New Product Development Engineer II

Biomerics•Brooklyn Park, MN

49d

About The Position

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' and patients' lives 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 strategic, mutually beneficial partnerships with customers and our team members. As a New Product Development Engineer II, you will be responsible for designing and developing catheters from concept to production that exceed customer expectations.

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 selection, verification and validation of 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. use of statistical techniques such as 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.

Responsibilities

Execute design, development, validation activities through product life cycle for development products in accordance with project scope
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 to MDR, ISO, EN standards
Understand customer specification/requirements and be able to translate into clear, 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 provide guidance to 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 updated 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.