Senior Product Development Engineer

Ancora Heart, Inc. • santa clara, ca, us • 18h ago

GENERAL INFORMATION

Position Title: Senior Product Development & Manufacturing Engineer

QUALITY RESPONSIBILITY

· Proactively support company goals and objectives, policies and procedures, Ancora Quality System, regulations, and regulatory requirements. Ancora Heart employees must demonstrate commitment to providing our customers with high quality medical devices.

PURPOSE OF JOB

· Support the company’s transition from clinical stage to commercialization within product design and improvements for manufacturability. Work closely with the R&D, Operations, and Quality Systems staff to improve existing processes and perform process validations. This hands-on role requires accountability and the ability to work with minimal supervision. This is an on-site position.

MAJOR DUTIES AND RESPONSIBILITIES

· Update product design as-needed to support high volume manufacturing

· DV tests, fatigue testing

· Design, document, assemble, and qualify production assembly / test / inspection fixtures and equipment.

· Specify, procure and implement off the shelf automated and semi-automated equipment

· Design, develop and implement custom equipment as-needed.

· Create verification or validation protocols, execute studies and/or tests, and author and release subject reports.

· Perform characterization studies and Design of Experiments (DoE).

· Author and perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).

· Write and maintain manufacturing documentation including material and component specifications, work instructions, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents.

· Maintain compliance with Ancora Heart’s quality systems including all applicable SOPs, non-conforming materials disposition, corrective action investigations and closure, and Engineering Change Order (ECO).

· Train operators on new processes, tools, and equipment.

· Work as the liaison among R&D, Operations, and Quality Systems to ensure a smooth transition of design changes, tooling, and fixturing.

· Assure product and process quality by designing testing methods; testing sub-assemblies, finished product and process capabilities.

· Develop, qualify and implement processes to improve manufacturability.

· Complete projects and tasks in a timely manner consistent with corporate objectives.

· Maintain compliance to QSR systems in coordination with the Document Control and Quality Assurance functions.

· Support company goals and objectives, policies and procedures.

· Perform other duties as assigned.

QUALIFICATIONS

EDUCATION REQUIREMENTS:

· Minimum B.S. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or similar Engineering discipline.

EXPERIENCE REQUIREMENTS:

· Minimum 5 years of related experience

REQUIRED SKILLS:

FDA, QSR and MDR regulations and relevant FDA Guidance and ISO standards
Experienced with SolidWorks
Strong background in IQ/OQ/PQ
Ability to work in a CER ISO 7 environment, engage with medical device assemblers to learn and understand current manufacturing challenges
Strong background in DFMEA, SHA, test methods, quality inspection methodology, report writing

· Willingness and ability to work independently and in teams