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.
Responsibilities, Skills & Hands-On Experience:
- 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
Education & Work Experience:
- 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.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $130,000 to $160,000 + equity + benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [redacted].
