R&D Manager

ASAHI INTECC USA INC•Tustin, CA

About The Position

This R&D Manager will lead direct and/or indirect reporting staff to take on new product development and product improvement projects to meet healthcare and business needs. This role will be a critical member of the cross functional team to deliver a portfolio of devices to drive expansion of the peripheral and vascular market segment. Be the leader to drive Asahi Intecc innovation DNA into every product to improve healthcare, resolve unmet needs, improve patient outcome, lifestyle and save lives.

Requirements

B.S. in a relevant engineering field, preferably Mechanical Engineering, Biomedical Engineering or similar engineering disciplines.
Minimum of 20 years of relevant experience, or advanced degree with a minimum of 15 years of relevant experience.
Strong understanding of Design Controls, and Phase Gate Product Development Process. Have experience working under ISO13485 and FDA 21 CFR 820 environment.
Have team management experience. Experience in manage projects with small-medium size team.
Experienced with designing minimally invasive interventional devices for applications in neurovascular, vascular, coronary, urological and/or peripheral areas.
Experienced in generating intellectual properties.
Experienced in leading a team through development cycle and launch a minimum of 2 products.
Have experience in generating engineering prints using Solidworks.
Have experience applying DMAIC, LEAN, Six Sigma, Agile, DFM, etc.
Have experience using AI tools in innovation process.
Have experience in using Minitab in statistical analysis.
Familiar with industry standards and regulatory guidelines.
Strong written and verbal communication skills. Fluent in English.
Hands-on experience with fabricating prototypes, assembly, and operating equipment.
Have working knowledge in thermoplastics, molding, welding, laser cutting, extrusion, Nitinol, catheter assembly technologies, and engineering mechanics.

Nice To Haves

Prefer to have budget, timeline and project management experiences.
Prefer to have animal study planning and coordination experiences.
Prefer to have process development experiences.
Prefer to have Six Sigma Black Belt.

Responsibilities

Lead the technical development of design solutions in interventional technologies.
Choose and integrate latest materials and processing technologies to generate innovative products.
Lead team to develop products from clinical need to successful commercialized product.
Plan physician discussions and animal studies, work directly with physicians and distil their inputs into product requirements and concepts.
Interface effectively with internal cross-functional team and extended team across multiple geographic locations to achieve project goals in a phase gate development process.
Direct, motivate, manage and develop team. Promote a culture that foster impactful fast innovations without sacrificing safety and quality.
Develop cost effective verification, validation and animal study strategies.
Design and validate novel test methods and measurement techniques.
Lead team to complete DHF and DMR deliverables and complete design reviews.
Prepare design specifications, design Input/output matrix, and define performance and interface requirements for molded/non-molded components and top assembly.
Onboard proper processing technologies and develop reliable process to deliver quality product meeting cost and quality targets.
Review and approve engineering documents. Create engineering documents, protocol and reports.
Generate intellectual properties and know-hows.
Effectively develop reliable project timelines.
Effectively coordinate and communicate technical information (oral, visual, written) in a clear and effective manner to management, customers, and cross-functional team members for high impact outcomes.
Support product transfer to pilot and high-volume production sites.