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Avalign Jobs (NOW HIRING)

avalign

Sr. Design Quality Engineer

Schaumburg, IL

The Design Quality Engineer will provide CTQ and DFI input internally while ensuring that Avalign specification development activities conducted by Research and Development (R&D) comply with ...

avalign

Sr. Financial Analyst

Greenwood, IN

$81K - $101K/yr

In addition to being support for the manufacturing sites, this position will also assist with various Avalign corporate/shared services month end close and reporting activities. What You'll Do:

Avalign Technologies

Sr. Financial Analyst

Mentor, OH · On-site

$76K - $95K/yr

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...

avalign

CNC Swiss Lathe Machinist - 1st Shift

Mentor, OH

$19.75 - $25/hr

We are looking for a CNC Lathe Machinist to join our Avalign Integrated Medical team located in Mentor, OH on a 1st shift schedule . The CNC Lathe Machinist operates conventional, special purposes ...

Avalign Technologies

Lead Maintenance Tech

Warsaw, IN · On-site

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...

avalign

Production Assembler - 2nd Shift

Greenwood, IN · On-site

$15.25 - $18.25/hr

If you are interested, please apply in person or via email to hr.greenwood@avalign.com. What You'll Do : * Assembles assigned product parts on assembly line in accordance with established procedures ...

Avalign Technologies

CNC Mill Machinist - 3rd Shift

Warsaw, IN · On-site

$21.25 - $28.25/hr

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...

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How much do avalign jobs pay per hour?

As of Jul 31, 2026, the average hourly pay for avalign in the United States is $26.34, according to ZipRecruiter salary data. Most workers in this role earn between $15.14 and $30.77 per hour, depending on experience, location, and employer.

What are the typical daily responsibilities of an employee at Avalign, and how does the team collaborate to meet project deadlines?

At Avalign, daily responsibilities often include collaborating with cross-functional teams to ensure the precision and quality of medical device components. Employees may participate in production meetings, review project timelines, and contribute to process improvements. Teamwork is essential, as projects frequently require coordination between engineering, quality assurance, and manufacturing departments to meet client specifications and regulatory standards. Open communication and regular progress updates help the team stay aligned and successfully deliver on tight deadlines.

What is an Avalign job?

An Avalign job typically refers to a position at Avalign Technologies, a company specializing in medical device manufacturing. Jobs at Avalign range from engineering and manufacturing to quality assurance and corporate roles. Employees work on designing, producing, and distributing precision surgical instruments and implants. Avalign offers opportunities in a highly regulated industry with a focus on innovation and quality.

What is Avalign and what does the company do?

Avalign is a medical device manufacturer specializing in precision instruments, implants, and other products used in orthopedic, spine, and other surgical procedures. The company partners with OEMs (original equipment manufacturers) and healthcare providers to deliver high-quality medical devices that support patient care. Avalign offers services ranging from design and engineering to manufacturing and assembly, ensuring strict compliance with regulatory standards. Their products are widely used in hospitals and surgical centers across the globe.

What are the key skills and qualifications needed to thrive as an employee at Avalign, a medical device manufacturing company, and why are they important?

To thrive at Avalign, professionals typically need a background in engineering, manufacturing, or quality assurance, often supported by relevant degrees or technical training. Familiarity with CAD software, ERP systems, and knowledge of ISO 13485 or FDA regulations are commonly required. Strong problem-solving skills, meticulous attention to detail, and effective teamwork help individuals excel in this environment. These capabilities are crucial for ensuring product quality, regulatory compliance, and the successful delivery of life-improving medical devices.

What is the difference between Avalign vs Surgical Technologist?

AspectAvalignSurgical Technologist
CertificationsTypically requires certification such as Certified Surgical Technologist (CST) or equivalentRequires CST or similar certification
Work EnvironmentManufacturing and assembly of medical devices, cleanroom settingsOperating rooms in hospitals or surgical centers
Industry UsageMedical device manufacturing industryHealthcare and surgical services industry
Job FocusDesign, assembly, and quality control of medical devicesPreparing operating rooms, sterilizing instruments, assisting during surgeries

While Avalign focuses on medical device manufacturing, Surgical Technologists work directly in surgical settings assisting during procedures. Both roles require certification and have overlapping industry relevance, but their daily tasks and environments differ significantly.

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Avalign jobs near you
Infographic showing various Avalign job openings in the United States as of July 2026, with employment types broken down into 77% Full Time, and 23% Nights. Highlights an 100% Physical job distribution, with an average salary of $54,791 per year, or $26.3 per hour.

Sr. Design Quality Engineer

Avalign Technologies

Schaumburg, IL • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 4 days ago

Avalign Technologies rating

8.2

Company rating: 8.2 out of 10

Based on 15 frontline employees who took The Breakroom Quiz

Job description

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer's quality specifications for each product we produce.
The Design Quality Engineer will be responsible for the quality and regulatory related activities associated with new product development. New product development activities will occur in the contract development context and in the specification developer context. These activities span all aspects of the new product development process. The Design Quality Engineer will advise customers in the contract development context how to incorporate Critical-To-Quality (CTQ) and Design-For-Inspection (DFI) into the development process. The Design Quality Engineer will provide CTQ and DFI input internally while ensuring that Avalign specification development activities conducted by Research and Development (R&D) comply with associated policies, procedures and work instructions as outlined in the design control elements of the Quality Management System (QMS).
The Design Quality Engineer will be responsible to ensure that regulatory compliant technical documentation is compiled and for ensuring the ongoing compliance of the technical documentation for assigned Avalign Technologies design owned products. The Design Quality Engineer will assist in regulatory filings for Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission.
A working knowledge of related global design regulations is required. (ISO 13485, ISO 14971, 21 CFR Part 820, and, preferably, EU Medical Device Regulation) The position requires a hands-on self-directed style, and the ability to influence and effectively communicate vertically, horizontally, across functions, externally with customers and internally with co-workers. The ideal candidate must demonstrate ability to self-direct, strong analytical abilities, and strong verbal and written communication skills. The position reports directly to the Director of Regulatory Affairs.
What You Will Do:
  • Responsible for supporting a design control quality system that is complaint to ISO 13485 (latest revision), the Medical Device Directives (while active), and the EU Medical Device Regulations (MDR).
  • Supports, reviews, and approves the following activities associated with new product development: identification and documentation of user needs, design inputs, outputs, verification, validation, risk assessment, and design change activities to demonstrate new product designs are supported by objective evidence in the design history file prior to product launch.
  • Participate in supply chain development through Avalign division and external supplier selection and qualification with the new product development team.
  • Participates in design reviews as required by the design control and development processes.
  • Serve as GD&T expert for contract developer and specification developer activities.
  • Assist project managers with design transfer planning and execution including advising on Avalign and vendor manufacturing process validations to support new product development.
  • Support processes for Medical Device Reporting and Complaints for Avalign as specification developer products.
  • Ensure required design documentation is retained in design history files and technical files to support regulatory submissions and audits.
  • Support and maintain all regulatory filings for all Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission.
  • Perform corporate internal audits, either as a supporting auditor or as the lead auditor.
  • Participate in external audits.
  • Conduct post market surveillance for contract development and specification developer products.
  • Ensure post launch product design file updates are completed following design change and post market surveillance activities.
  • Write or update standard operating procedures, work instructions, or policies.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Assist in investigations of product complaints, root cause analysis, corrective action, trending and make recommendations regarding their reportability.
  • Investigate and complete records related to assigned Nonconformances and CAPAs.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or other compliance issues.

What You Will Need:
  • Bachelor degree or equivalent experience in an engineering or scientific field
  • 5+ years of experience in quality and/or engineering role
  • 2+ years of experience in medical device industry, preferred
  • 2+ years of experience in quality within design control activities supporting new product development, preferred
  • Experience with ISO 13485, FDA 21 CFR 820 Quality System Regulation, ISO 14971, MDR, or associated regulations.
  • Ability to travel up to 25%

Preferred Qualifications
  • Expertise in project management and problem solving skills, including the ability to identify, investigate and resolve technical and/or systemic issues.
  • High attention to detail and persistence in resolving discrepancies
  • Excellent interpersonal communication (written and verbal) skills and ability to communicate at all levels of the organization and with suppliers and customers
  • Familiarity with Quality System Management software
  • Familiarity with regulatory submissions including:
    • Coordinating efforts associated with the preparation of regulatory documents or submissions.
    • Preparation or review of regulatory submissions for domestic or international projects.

What You Won't Do:
  • Feel stuck - we offer great opportunities to advance and learn
  • Get bored - we make a high variety of products, so no day is the same
  • Feel like a number - we're a close-knit bunch and always have each other's backs

Who You Are:
  • A self-starter who thrives in a fast-paced environment
  • A quick learner who is always ready to gain depth of knowledge in manufacturing processes
  • A reliable individual who knows the importance of showing up when it counts
  • Someone who accept assignments with an open, cooperative, positive and team-oriented approach
  • Someone who is able to plan and execute plans across teams
  • An effective communicator, both written and verbal

What You'll Enjoy:
  • Competitive compensation and benefits package
  • Comprehensive medical, dental, and vision insurance
  • Paid vacation and 10 observed paid holidays per year
  • Employer funded Basic Life and AD&D insurance
  • Employer funded STD and LTD insurance
  • Tuition reimbursement
  • Great 401(k) with company match
  • Generous employee referral bonus program
  • Working for a thriving, performance-based company that values promoting from within and career advancement
  • Temperature controlled environment
  • Community involvement investing and giving back to the community
  • Additional free resources such as travel assistance, EAP, etc.

Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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