Spectrumedics International – R&D Engineer (Medical Device)

PROJECT DESCRIPTION

To develop a class III transcatheter cardiovascular implant and its delivery system

ESSENTIAL JOB FUNCTIONS

• Design and develop cardiovascular-based products.
• Develop cardiovascular implants, catheters and catheter assemblies/subassemblies according
• to user needs and product specifications.
• Perform process-related tasks to support pilot manufacturing. Manage process development
• and optimization activities during pilot manufacturing and transfer.
• Participate on multiple cross-functional development teams that manage projects from
• concept through commercialization.
• Analyses, evaluates, sources, and coordinates the procurement of new materials to support
• prototyping and pilot operation.
• Plans and develops initial fabrication steps and test plans for prototypes.
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and
• validation testing.
• Execute protocols, collect data and maintain lab notebook according to company policy and
• quality system.
• Analyse test data and generate draft reports determining if designs meet functional and
• performance specifications for Design and Engineering review.
• Identify suppliers and maintain relationships.
• Analyses, evaluates, and recommends cost, design or process improvement ideas through
• product, vendor, and design changes
• Enhance the intellectual property position of the company via invention disclosures and
• patent applications.
• Maintain current knowledge of competitive technologies in addition to medical, technical,
• and biomedical developments related to company's products.
• Responsible for component and assembly documentation for new products being developed.
• Other duties as assigned.

REQUIREMENTS

• A minimum of a Bachelor’s Degree in Mechanical, Biomedical, or Material engineering. Postgraduate degree preferred.
• Minimum of 3 years’ engineering experience in the medical device industry.
• Technical expertise in cardiovascular product design, development, material selection,
• testing, manufacturing and verification preferred
• Must possess good interpersonal and communication skills, and work in a collaborative style.
• Good technical skills and proven engineering problem solving ability.
• Experience developing sterile, disposable medical devices.
• Experience with Solidworks
• Experience with early stage cardiovascular devices development is a strong plus.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing
• requirements.