Design Quality Engineer

Description

The company designs and manufactures medical technology that aims to expand what people can do in daily life.

You would join the ENT New Product Development team in Austin WC to help take safe, dependable medical devices from early concept through development.

The role offers a chance to grow your quality engineering skills while working with colleagues across functions to make sure new products meet strict quality and regulatory standards.

Responsibilities

• Support design controls and quality work such as design verification and validation, sterilization and process validation, supplier qualification, test method development, capability studies and risk management files.
• Create methods and procedures that confirm products meet their specifications and standards, and show that safety and reliability are established through suitable testing.
• Give manufacturing teams support on product requirements, risk management, test methods and statistical analysis.
• Help keep products compliant with applicable quality and regulatory rules, including cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and MDR.
• Work with outside labs and suppliers to explain product and process requirements and evaluate what they can do.
• Support improvement work covering CAPA, nonconformances and internal audits.
• Contribute to post market surveillance, management review, and audit and inspection activities.

Requirements

• Bachelor's degree in engineering.
• 0 to 2 years of experience in medical devices or a closely related field, with a general or basic grasp of design control and standards such as FDA CFR 820, ISO 13485, EU MDR and GxP.
• Ability to juggle multiple projects, tasks and deadlines while contributing well within a team.
• Clear written and spoken communication, plus proficiency in Excel and AI tools.
• A statistics background is preferred.
• Travel under 5% of the time.
• This role is not eligible for employer-sponsored immigration support. You must already be authorized to work in the United States and must never need company sponsorship to keep that authorization.

Conditions

The role is based in Austin WC and follows a hybrid work model, which applies to most professional positions.

The company is committed to inclusion and belonging for all employees.

Benefits

• 401k matching and a 401k Plus program.
• Discounted stock purchase plan.
• Tuition reimbursement.
• Flexible personal and vacation time off, paid holidays, flex holidays and a paid community service day.
• Medical, dental and vision coverage, plus a health savings account with an employer contribution of $500+ per year.
• Employee assistance program, parental leave, and fertility and adoption assistance.
• Hands-on, team-tailored training and mentorship.
• Discounts on fitness clubs, travel and more.