Pharmavise Corporation · 20 hours ago
Senior R&D Engineer — Medical Device (Onsite — Arbor Lakes, MN) Possible Temp\-to\-Hire
Osseo, Minnesota, United States
Full-time
Onsite
Senior Level
5+ years expPharmavise Corporation is seeking a Senior R&D Engineer for their F500 Medical Device client. The role involves conducting development work for major research projects, providing guidance to teams, and managing project goals while ensuring compliance with regulatory standards.
Food and BeverageHealth Care
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
Assesses 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
Qualification
Required
Minimum of a bachelor's degree in mechanical or biomedical engineering (or other related technical discipline)
5+ 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
Self-motivated with a passion for solving problems and a bias for action
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
Ability to effectively work and collaborate in a mixed onsite + remote environment
Demonstrated experience creating detailed technical documents
Preferred
Experience working with medical devices such as catheter or delivery systems
Quality Integration experience
510k regulatory experience
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
Adaptable and effective collaborator in a team environment or in self-directed work
Experience with design changes, complaint reduction, and corrective action
Company
Pharmavise Corporation
♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2020-04-04Seed
Leadership Team
Ricardo Joseph
Founder and CEO
Company data provided by crunchbase