Senior (Quality Engineer 4) - Multiport Da Vinci Systems

Description

The company designs and manufactures complex surgical systems, including cameras, instruments and accessories used in surgery.

The team is developing next generation products, and this role is a core member of the cross-functional group that takes products from concept through commercialization.

You are a strong quality leader who brings expertise in design controls, risk management, process validation, and design for reliability and manufacturing.

You make sure products meet the company's quality processes and all external design control and regulatory requirements.

Responsibilities

• Help plan and carry out design controls, risk management, and design verification and validation for new products.
• Help build the design history file so it meets internal processes and external standards and regulations.
• Make sure user needs turn into the design and meet usability and human factors standards and rules.
• Work with engineering to set design inputs, design outputs and traceability matrices.
• Shape and run risk-based design verification and validation.
• Help build the product risk management file, assessing risks that come from users, design, process and suppliers.
• Review architectures, selections, requirements and drawings from the early stages to make sure reliable, scalable designs move into manufacturing.
• Work with manufacturing, purchasing, test and supplier engineering to bring scalable designs into production.
• Help select, qualify, certify and improve suppliers.
• Take part in technical reviews and design reviews for new products.
• Help Regulatory Affairs prepare submissions and answer questions about them.
• Prepare for internal and external audits and speak directly with auditors.
• Help improve the quality processes and methods for design controls and risk management.

Requirements

• You have 8 years of related experience and a university degree in electrical engineering, mechanical engineering, computer science, software engineering, or biomedical engineering, or 5 years of relevant experience and an advanced degree.
• You know medical device standards such as ISO 14971, IEC 60601, IEC 62304, ISO 80002-1 and FDA design controls.
• You have run risk-based verification and validation, process validation, and limit or challenge testing.
• Experience with reliability principles, reliability testing, and reliability growth planning and execution is preferred.
• Experience running verification and validation testing is preferred.
• You can work through quality systems with little oversight on individual projects.
• You make balanced risk decisions that protect product quality, build consensus, and resolve technical challenges.
• You solve complex problems with little oversight and explain complex information clearly to teams, including executive management.

Conditions

Proof of current vaccination against certain diseases, including COVID-19, may be required by the company or its customers, depending on the role.

Some roles are subject to U.S. export controls under the Export Administration Regulations (15 CFR 743.13(b)), which can affect prospective employees who are nationals of embargoed or sanctioned countries.

For export-controlled roles, final offers depend on an approved export license and/or an executed Technology Control Plan before the start date; licensing can take 3 to 6+ months, and a control plan typically adds 2 weeks to hiring, with candidates notified if it applies.

Qualified applicants with arrest and conviction records are considered in line with fair chance laws.

Preference goes to qualified candidates who do not live, and do not plan to live, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

The role may be filled at a different job level depending on business need and the selected candidate's experience, knowledge and skills.

Pay is based mainly on the job level the role is filled at and the candidate's qualifications, as allowed by law.