About this role: Sr. R&D Engineer
Our client is a small but rapidly growing medical device company focused on improving patient outcomes through innovative cardiovascular and other medical devices. Core catheter technologies and methodologies set our client apart including novel catheter braiding and coating applications.- Identify product design and process improvements for new and existing products. Justify, implement, verify and validate solutions toaccomplish cost, quality and schedule goals for new and existing products. Represent development and/or manufacturing on newproduct cross-functional teams to accomplish design goals to ensure compliance with good documentation practices, safety, qualitystandards, and customer needs.
− Design and implement test fixtures for testing and programming of final products.− Develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures that supporta Lean manufacturing environment.− Develop and maintain the documentation necessary to ensure design controls and the consistent manufacture of products (processes,
drawings, routings, and maintenance).− Provide engineering expertise for troubleshooting of process or product issues, including root cause failure analysis of discrepantmaterials and assemblies, including CAPA activities.− Write and perform electrical, mechanical, material and equipment tests, gather data, interpret results, and write reports.
− Train manufacturing employees on new and revised products, tooling and processes.− Specify and procure equipment and oversee outside vendor activity as required.− The ability to successfully work with new technologies and methods on new designs and upgrades to existing designs.− Complete process validations to meet applicable FDA and regulatory requirements for components and finished goods devices.
− Review, understanding and implementation of applicable industry standards− Supplier management for selection, maintenance and capability of quality product− Test method development and validations for equipment and processes− Project management of fixtures and device projects including detailed project plans with team input to manage all aspects of product
development and production− Statistical methods for reliability and capability of products specifications and testing− Risk management tools and practices per ISO 14971− Identify opportunities to improve AUST’s capabilities, business practices, workflows, etc
− Work hands on to resolve issues quickly and proactively.− Contribute to the companies Intellectual Property through development of designs and processes worthy of patent filing and/or trade
− Strong team player, works well with all levels of employees, collaboratively and respectfully in a team environment− Excellent problem-solving skills− Understands engineering principles, theories, concepts, practices and techniques and applies them to daily activities− Solidworks or other 3-D solid modeling experience
− Must be able to prioritize multiple projects and responsibilities and meet key deadlines− Previous Catheter or other Medical Device experience− Machine shop and/or other prototyping experience− Experience with quality systems and the FDA or other regulatory bodies
− Familiarity with ISO 13485 and GMP− 5+ years experience in a medical device manufacturing environment
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Any questions remaining?
Your consultant, Kenneth McGreevy is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel USA - Boston