Sr. Process Development Engineer

Shifamed•Los Gatos, CA

16h•$130,000 - $160,000

About The Position

Akura Medical, a Shifamed portfolio company, is seeking a highly skilled and motivated Senior Process Development Engineer. This position will help design and develop processes for catheter, nitinol and console manufacturing. You will be responsible for hands-on design, development, and manufacturability of the company’s products including specific products, subassemblies, and components. You will be directly involved in development and problem-solving in a wide range of areas including assembling handling methods, component manufacturing, process optimization, equipment selection and operation and verification & validation activities.

Requirements

Bachelor's, or Master's, degree in an Engineering discipline.
5-8 years of medical device industry experience.
Experience with design for manufacturing and process development for stent manufacturing (laser cutting, shape setting, microblasting, electropolishing).
Experience with design and fabrication of assembly fixtures.
Tool and fixture design on Solidworks or equivalent Lab and clean room environment exposure.
Excellent communication skills, ability to work independently or in project team setting.
Experience with Nitinol material properties and processing Catheter manufacturing (braiding, lamination, tip forming, thermal bonds)
Process ownership from concept to commercialization Lean manufacturing/Six Sigma
Experience working under quality systems designed to meet governmental regulations.
Familiarity with FDA QSR, ISO 13485.
Must be proficient in Solidworks/CAD Comfortable working in a clean room environment.

Responsibilities

Provide creative solutions to satisfy unmet clinical needs through creation of innovative processes and methods of manufacture.
Work as part of a cross-functional team to develop, optimize, verify, and validate processes through bench, in-vitro, and in-vivo testing.
Effectively document work throughout the development process inclusive of lab notebooks, design reviews, manufacturing process instructions (MPIs), equipment qualifications, and process validation.
Research, develop, modify and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
Drive and provide support to quality processes and applying formal problem-solving techniques to determine root cause, and implementing solutions (non-conformance, CAPA, change management, audits, product complaint investigations, etc.).
Design, execute, and analyse experiments using sound statistical methodology.
Participate in risk management activities, including development and ownership of process FMEAs.
Support product verification and validation activities by developing test protocols and writing test reports.
Select and manage critical suppliers and vendors.
Provide technical support for regulatory/clinical, marketing, and/or sales efforts