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Specification Engineer Jobs (NOW HIRING)

Avalign Technologies

Sr. Design Quality Engineer

Fort Wayne, IN · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

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.

avalign

Sr. Design Quality Engineer

Fort Wayne, IN · On-site

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.

City of Rowlett

Public Works Engineer

Rowlett, TX · On-site

$57K - $64K/yr

  • Medical

  • Dental

  • Vision

  • PTO

Inspect projects for compliance within standards and specifications of the contract and within the ... Engineering Standards / Development Code: * Creates, updates, and maintains numerous reference ...

Cypress HCM

Senior Verification Engineer

Suwanee, GA · Hybrid

$150K - $225K/yr

Interacting with design, product, and spec engineering teams internally * Contributing to silicon debugging as needed * Developing, driving, and implementing UVM SystemVerilog TestBench ...

GCW, Inc.

Specification Technician

Las Vegas, NV · On-site

Possesses knowledge and understanding of civil engineering specification writing methodologies and procedures, including contract documents and bidding procedures. * Has knowledge of CSI guidelines ...

TalentForge360

Software Engineer

Phoenix, AZ · Remote

$110K - $135K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Determines and designs system specifications, standards, and programming to prepare and install solutions. Requirements * Bachelor's degree in Software Engineering, Information Technology or related ...

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Specification Engineer information

See salary details

$39K

$101.8K

$137.5K

How much do specification engineer jobs pay per year?

As of Aug 19, 2026, the average yearly pay for specification engineer in the United States is $101,752.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,000.00 and $116,500.00 per year, depending on experience, location, and employer.

What does a specification engineer do?

A Specification Engineer is responsible for developing, reviewing, and managing technical specifications for products, materials, or systems to ensure compliance with industry standards and project requirements. They collaborate with design, engineering, procurement, and manufacturing teams to ensure specifications align with functionality, quality, and regulatory standards. Their role often involves researching materials, writing detailed documentation, and updating specifications based on technological advancements or regulatory changes.

What are the key skills and qualifications needed to thrive as a specification engineer?

To thrive as a Specification Engineer, you need a solid background in engineering principles, attention to detail, and the ability to interpret technical documents, typically supported by a degree in engineering or a related field. Familiarity with CAD software, Product Lifecycle Management (PLM) systems, and relevant industry standards or certifications such as ISO is often required. Strong analytical thinking, communication, and collaboration skills help drive consensus between cross-functional teams. These skills are crucial for developing accurate specifications that ensure product quality, compliance, and successful project outcomes.

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What are the most commonly searched types of Specification Engineer jobs?

The most popular types of Specification Engineer jobs are:

What states have the most Specification Engineer jobs?

States with the most job openings for Specification Engineer jobs include:

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Specification Engineer jobs near you
Infographic showing various Specification Engineer job openings in the United States as of August 2026, with employment types broken down into 89% Full Time, 2% Part Time, and 9% Contract. Highlights an 96% In-person, 2% Hybrid, and 2% Remote job distribution, with an average salary of $101,752 per year, or $48.9 per hour.

Sr. Design Quality Engineer

Avalign Technologies

Fort Wayne, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 23 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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