Senior Mechanical Sustaining Engineer

MMI - Medical Microinstruments, Inc.; Pisa; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading medical device company in Pisa, Italy, seeks a skilled Sr. Mechanical Sustaining Engineer to support and improve products and manage product lifecycle. Candidates should have experience in regulated industries and be detail-oriented. This role offers an exciting opportunity in a growing company focused on improving patient care, with chances for career advancement.

Servizi

Career advancement opportunities

Collaborative team environment

Competenze

• At least 5 year experience on similar roles.
• Expert in Design Control process.
• Experience in medical quality systems such as GMP and ISO13485.

Mansioni

• Proposal and Execution of design changes to satisfy performance, quality, and manufacturing needs.
• Perform technical investigations and root cause analysis.
• Collaborate with Quality Assurance to manage product quality events.

Conoscenze

Mechanical design

Problem-solving

Root cause analysis

Collaboration with Quality Assurance

Formazione

Mechanical or Aeronautical Engineering Degree

Strumenti

3D CAD (SolidWorks preferred)

Descrizione del lavoro

Want to join a motivated team of 220+people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced medical device industry?

Medical Microinstruments Inc is looking for people with a passion for innovation and a dedication to excellence.

At MMI we are building the future of microsurgery. The Symani platform provides the surgeon with the capability to operate on a small scale with ease and precision, thanks to the Symani platform and a variety of Instrument types.

We’re seeking a skilled and proactive Sr. Mechanical Sustaining Engineer to support and improve our existing products. You’ll manage product life-cycles, reduce costs, boost reliability, and ensure compliance with evolving regulations. With experience in regulated industries like medical, aerospace, or automotive, you’ll work closely with R&D to align changes with customer needs. If you’re detail-oriented and passionate about quality, we’d love to meet you!

Roles & Responsibilities

Your main responsibilities day-to-day will include :

• Proposal and Execution of design changes to satisfy Performance, Quality and Manufacturing needs on existing products.
• Perform technical investigations, root cause analysis of failures, tests and proposing product or parts technical remediation.
• Collaborate with Quality Assurance to manage Product Quality Events (QE) and Complaints (CMPL)
• Development of test protocols, testing equipment and conduct validation test
• Updating Manufacturing product items to improve parts’ quality and reliability. Modification of drawings (for example tolerances and CTQs), specifications, or selecting different supplier or different production methods.
• Identification and promotion of Manufacturing process optimization or change to improve quality, reduce lead-time or costs, both for external and internally produced parts.
• Driving problem solving processes (A3 DMAIC) to solve everyday issues.

Requirements

At least 5 year experience on similar roles.

Mechanical or Aeronautical Engineering Degree.

Expert in Mechanical design.

Expert in Design Control process.

This is an exciting opportunity to gain further exposure to a manufacturing environment, but if you have some experience in the following that would be a bonus :

A minimum of 3 year experience working in a biomedical field

Medical Quality System knowledge (e.g. GMP, ISO13485 and / or FDA CFR21 Part 820).

Experience with 3D CAD (SolidWorks preferred)

Experience in design of motorized joints, stages or actuated mechanisms

Experience in design and manufacture of micro-mechanical mechanisms, and familiarity with the handling and assembly issues related to small parts.

Experience in Wire EDM fabrication, Plastic moulding and joining processes.

Surface treatment and coatings.

Basic knowledge of biocompatibility, sterility and cleaning process.

Knowledge of manufacturing processes to influence design choices and to ensure ease of manufacture and test.

Hands-on experience of mechanical, electronics and software engineering disciplines (such as systems / mechatronics engineering).

Equipment or process qualification (e.g., FAT, SAT, IQ, OQ, PQ)

About MMI

MMI is dedicated to improving reconstructive options for surgeons and patients and has developed the first teleoperated robotic platform for open microsurgery. It offers the surgeon motion scaling and tremor elimination and aims to facilitate existing procedures as well as enable new ones in the domain of microsurgery, from post-oncological and trauma reconstructions to ophthalmology, organ transplantation and pediatric surgery.

What we offer

An exciting and challenging role based in Pisa, Italy. Working in a fun and growing company that is dedicated to improving patient care. The chance to learn new skills under the direction of experienced colleagues with career advancement opportunities.

Join Us

Are you seeking an opportunity to make a real difference in a med-tech company with the aim of improving patient care?

Join us and grow with a team of energy people who will motivate and inspire you!

Interested? We would love to hear from you!

MMI is committed to creating a diverse work environment and is proud to be an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, pregnancy, age, disability or other characteristics protected by law.