Bachelor's degree in mechanical or biomedical engineering or related technical discipline.
4+ years in design assurance or new product development in a regulated medical device industry.
Experience with medical devices, specifically catheter or delivery systems preferred.
Skilled in design controls, print packages, and tolerance analysis with GD&T knowledge.
Proficient in Windchill and SolidWorks for 2D drawing creation.
Understanding of ISO 13485, ISO 14971, and Quality System Regulations, particularly in Design Controls and Risk Analysis.
Proven problem-solving capabilities and experience facilitating the problem-solving process.
Responsibilities
Collaborate with a focused team of product design engineers on a new large bore delivery catheter.
Independently create essential deliverables for a 510k regulatory submission, including CAD designs and detailed print packages.
Offer guidance to product and technology teams based on expertise in in-house technologies.
Evaluate the feasibility of alternative engineering processes and products.
Manage and document project goals, progress, and recommend necessary revisions.
Develop and mentor others on engineering documentation practices.
Utilize PDP/TPD system knowledge to ensure high-quality deliverables.
Benefits
Collaborative and innovative team environment.
Opportunity to work on next generation medical technologies.
Minimal technical oversight allows for autonomy.
Impactful role with the potential for professional growth.
Chance to contribute to significant regulatory submissions for medical devices.
Full Job Description
Job Description:
Independently conducts development work as part of a major research and/or development project.
Receives minimal technical direction/review on broad scope or complex projects.
Viewed as an expert in one or more in-house technologies.
Focused on next generation access and delivery catheter. 510k submission by next year
Operating in a 510k submission lens
Responsibilities:
Work with a small team of new product design engineers focused on the design of a new large bore delivery catheter.
Works independently to develop key deliverables as part of a 510k regulatory submission. Deliverables include, but not limited to: CAD design, detailed print packages, specification generation and rationale, specification mapping to essential design outputs, DFMEAs, tolerance analysis, device material assessment(s), and bill of materials.
Provides guidance to product and technology teams.
ssesses the feasibility and soundness of alternative engineering processes, products, or equipment.
Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
Develop and coach others on engineering documentation.
Demonstrates PDP/TPD system knowledge through coaching and delivery of high quality, high impact deliverables.
Qualifications:
Minimum of a bachelor's degree in mechanical or biomedical engineering (or other related technical discipline).
Experience working with medical devices (catheter or delivery systems is highly preferred).
4+ years of experience in design assurance, new product development or related medical device / regulated industry experience.
Experienced in design controls, print packages, tolerance analysis, GD&T.
Windchill and SolidWorks experience (ability to create 2D drawings).
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
Experienced problem solver, capable of facilitating the problem-solving process.
daptable and effective collaborator in a team environment or in self-directed work.
Experience with design changes, complaint reduction, and corrective action.
Preferred Qualifications:
Experience working with catheter or delivery systems.
