Senior Design Quality Engineer - Biomerics LLC : Job Details

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 the design, development, and production of 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' lives, and the lives of the patients that depend on our products.

At Biomerics we believe in 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 as well as our team members.

Biomerics is a leading provider of laser processing services and contract manufacturing of medical components and assemblies to a wide range of customers throughout the United States and internationally. The company develops and implements leading-edge part-specific manufacturing processes utilizing such high-tech manufacturing tools as rapid prototyping, automation, PLCs, robotics, and vision systems.

The company offers a uniquely friendly and supportive environment and strongly encourages its employees to learn and grow in their careers. The company offers its eligible employees a range of benefits which include medical and dental benefits, 401K, and paid time off.

JOB DESCRIPTION:

The Senior Design Quality Engineer supports the Design and Development group to ensure devices, components, and materials in development comply with Biomerics' SOP's and applicable regulations and standards.

• Manage deliverables from the design process including DHF and Engineering Project File documents. Examples: Design Trace Matrix, DFMEA, Design Verification Protocols and Reports, Test Method Validations
• Collaborate with Design Engineers and Technicians in the development of project deliverables
• Participate on design teams to assure customer product requirements, as well as quality requirements, are documented and addressed
• Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified
• Lead design teams in the performance of DFMEA, PFMEA and Risk Management activities
• Effectively employ problem-solving tools/methodology, including Root Cause Analysis
• Assist with the development of inspection processes and equipment
• Support Manufacturing Engineering, Operations, Business Development, and Quality, during concept, prototyping, and transfer of new products into production
• Assure that design specifications are accurately translated into production/process specifications
• Support Quality System improvements
• CAPA ownership and support
• Other assignments as requested

Requirements

• Bachelor's Degree/Technical Degree in Engineering or equivalent experience
• Minimum 5 years' experience in a Medical Device manufacturing/product development environment
• Working knowledge of FDA QSR's, ISO 13485, and ISO 14971 requirement
• Experience/knowledge with product/process verifications/validations
• Experience with DFMEA's, PFMEA's and Risk Management
• Statistical Analysis (Six Sigma preferred), including use of Minitab Statistical Analysis software (or equivalent)
• Driven, energetic, self-assured professional with high personal integrity
• Ability to develop effective, positive interpersonal relationships, and lead activities across cross-functional teams
• High sense of urgency and commitment to execution
• Good time management skills and initiative in taking on and completing projects/deliverables
• Able to manage and prioritize multiple projects/objectives
• Excellent verbal and written communication skills
• Strong customer management skills
• Microsoft Office software

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

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 of Biomerics' salary range.

Biomerics does not accept non - solicited resumes or candidate submittals from search/recruiting agencies that are 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.