Full-Time

Principal Manufacturing Engineer

Posted on 12/3/2025

Deadline 1/9/27
Werfen

Werfen

1,001-5,000 employees

Global specialized diagnostics provider

Compensation Overview

$160k - $190k/yr

+ Commission + Performance-based Bonus

Bedford, MA, USA

In Person

Category
Mechanical Engineering (1)
Requirements
  • B.S. in Engineering and a minimum of 15 years of experience or an M.S. Degree and a minimum of 10 years of experience
  • Experience in technical support for the manufacturing of instrumentation and/or disposables preferred
  • Experience in Lean and Six Sigma problem solving methodologies preferable
  • International Mobility Required: No
  • Travel Requirements:<5% of time
Responsibilities
  • Responsible for the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions
  • May be required to act as Product Champion for a specific product or product line with the following leadership responsibilities: The focal point in operations for the products which they have responsibility for
  • Leads the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause{s), develop and implement solutions
  • Leads the process engineering and production support activities required for the manufacture of a product line
  • Provides technical support and leadership for continuous improvement team efforts focused on process improvement and improvements to product manufacturability
  • Provides technical leadership and hands-on engineering support, including specification and implementation of asse
  • Responsible for establishing the Manufacturing Quality Plan (MQP) for a product or product line including process flow, production floor layout, equipment, line balancing, etc.
  • Writes process procedures, change orders, equipment specifications, validation plans, and reports
  • Performs research on technology, equipment and tooling to improve process quality, yield or cost
  • Generates proposals for purchase and implementation, including cost of ownership, ROI and benefit analysis
  • Performs engineering design of test equipment, assembly equipment, fixtures and tools; Performs IQ/OQ/PQ validation activities
  • Participates in the introduction of new products into manufacturing; Collaborates with R&D and suppliers to improve product robustness and manufacturability both pre- and post-release
  • Supervises as assigned personnel in classifications below that of Senior Mfg. Engineer
  • May lead or participate in Lean Six Sigma projects of significant scope and complexity

Werfen focuses on in vitro diagnostics, offering specialized diagnostic solutions for healthcare. It provides tests and instruments for areas like hemostasis (blood clotting), acute care diagnostics, and autoimmunity, used by clinical laboratories to detect and monitor diseases. The company's products combine diagnostic assays, reagents, and instrumentation that run in laboratory workflows to produce actionable patient results. Werfen differentiates itself through its long-standing family-owned heritage, strategic growth including the 1991 acquisition of Instrumentation Laboratory, and a global footprint that spans 30 countries with active presence in more than 100 territories. The goal is to improve patient care by expanding access to accurate, high-quality diagnostic tools and services while maintaining a strong commitment to quality and specialized solutions.

Company Size

1,001-5,000

Company Stage

Debt Financing

Total Funding

$550M

Headquarters

Barcelona, Spain

Founded

1966

Simplify Jobs

Simplify's Take

What believers are saying

  • Omixon acquisition on October 16, 2024, bolsters NGS transplant diagnostics.
  • 169,000 SF R&D facility opened December 3, 2024, in Bedford, MA drives innovation.
  • Seegene partnership establishes PCR diagnostics company in Spain.

What critics are saying

  • Seegene undercuts Werfen's OEM with superior multiplexing in Europe now.
  • Roche's cobas t 711 displaces ACL TOP hemostasis systems immediately.
  • Abbott's Alinity i steals QUANTA Flash autoimmunity contracts this year.

What makes Werfen unique

  • Werfen leads in hemostasis, acute care, and autoimmunity diagnostics worldwide.
  • Family-owned since 1966, operates in 30 countries with €2.1B 2024 sales.
  • Unifies brands like Instrumentation Laboratory under Werfen for global coherence.

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Benefits

Remote Work Options

Company News

TradingView
Mar 10th, 2026
AcouSort receives prepayment of royalties

AcouSort receives prepayment of royalties. AcouSort AB today announced the signing of an amendment to its license and distribution agreement with the leading blood-gas analyzer company, Werfen. Under the amendment, Werfen will prepay minimum royalties for 2027 and 2028. Together with Werfen's regular 2026 minimum royalty, the total sum payable to AcouSort in early 2026 amounts to approximately USD 1.3 million. "Based on our current cash position and this prepayment together with Werfen's regular 2026 minimum royalties alone will fund AcouSort into 2027," said AcouSort's CEO Dr. Torsten Freltoft. The original agreement was signed in spring 2018. Using AcouSort acoustofluidic background technology, the parties jointly developed the solution now implemented in Werfen's groundbreaking GEM Premier 7000 system for point-of-care blood gas analysis. The hemolysis detection in GEM Premier 7000 is based upon patented acoustofluidic technology for plasma separation, combined with photometric determination. In just 45 seconds, the GEM Premier 7000 detects hemolysis, while delivering a complete menu of blood-gas results (pH, pO2, pO2, sodium, potassium, ionized calcium, chloride, glucose, lactate, hematocrit, total hemoglobin, total bilirubin and CO-Oximetry). No other terms of the License and Distribution Agreement with Werfen have been changed. In terms of liquidity, the change takes effect within Q1, while revenue recognition occurs according to applicable accounting principles. This information is information that AcouSort is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-03-10 17:30 CET. FOR FURTHER INFORMATION ABOUT ACOUSORT, PLEASE CONTACT: Torsten Freltoft, CEO Telephone: +45 2045 0854 E-mail:[email protected] ABOUT ACOUSORT AcouSort AB (corporate registration number 556824-1037) is an innovative technology company focusing on developing products and solutions for integrated preparation of biological samples. With the help of sound waves, the company's products can separate blood cells, concentrate, purify, and stain cells, exosomes, and bacteria from biological samples. The technology of the company's products is acoustofluidics, where sound waves and microfluidics enable automated handling of samples in a range of application areas, from research on new biomarkers to the development of new diagnostic systems for near-patient testing - so-called Point-of Care (POC) systems. The company's commercialization strategy is based on the already proven business model of providing separation modules to diagnostic system manufacturers for integrated sample preparation as well as to continue the commercialization of the company's research instruments. With the help of the company's products and development of point-of-care tests, new diagnostic systems and treatments are enabled, addressing some of the most challenging disease areas of our time: cancer, infectious diseases, and cardiovascular diseases. AcouSort is listed at Nasdaq First North Growth Market. The company's Certified Adviser is Tapper Partners AB. Attachments AcouSort receives prepayment of royalties

BioTecNika
Jan 5th, 2026
Biological Sciences Manufacturing Job at Werfen North America | Apply now

Biological sciences manufacturing job at Werfen North America | Apply now. Manufacturing Associate role at Werfen North America. Werfen North America is hiring for a Manufacturing Associate 1 position in San Diego, CA. This manufacturing job offers an opportunity to work in a regulated life sciences environment, supporting the production of advanced autoimmune diagnostic products used by clinicians worldwide. The Manufacturing Associate role is ideal for candidates seeking hands-on experience in diagnostic kit manufacturing while working with automated equipment and quality-driven processes. Job details: * Job Title: Manufacturing Associate 1 * Location: San Diego, California * Industry: Life Sciences / Diagnostics Manufacturing * Employment Type: Full-time * Department: Autoimmunity Manufacturing * Salary Range: $25/hr to $30/hr * Team: QUANTA Flash and Aptiva Manufacturing Team About Werfen North America: Werfen North America is a global leader in specialized diagnostics, focusing on autoimmune, hemostasis, acute care, and transfusion medicine. The company is committed to delivering high-quality diagnostic solutions that help healthcare professionals improve patient outcomes. Werfen North America operates under strict quality systems and regulatory standards, ensuring innovation, safety, and reliability across all manufacturing processes. Apply for more similar Manufacturing job offers in the USA. Educational requirements: * Bachelor's degree in biological or related sciences is required * Certificate program or Associate's degree with 3 - 4 years of relevant life sciences laboratory experience may be substituted * Relevant work experience may be considered in place of formal education at management's discretion Key responsibilities for Manufacturing Associate role: * Follow standard operating procedures and work instructions under supervision * Manufacture and test in-process components and diagnostic reagents * Participate in bulking and evaluation of reagents and components * Operate, clean, and maintain manufacturing equipment and instrumentation * Package and fill components according to manufacturing procedures * Maintain accurate Device History Records and related documentation * Assist with evaluation of raw materials when required * Ensure compliance with ISO, FDA, and Quality Management System regulations * Maintain a clean, safe, and organized lab and work environment * Reflect Werfen values in daily work and team interactions Skills required for Manufacturing Associate role: * Basic knowledge of laboratory practices and procedures * Understanding of Good Manufacturing Practices (GMP) * Strong attention to detail and quality standards * Ability to identify product defects or equipment issues * Problem-solving and troubleshooting skills * Effective time management skills * Ability to work collaboratively in a team environment * Willingness to learn and adapt in a regulated manufacturing setting Benefits of the Manufacturing Associate role: * Competitive hourly pay ranging from $25 to $30 per hour * Medical, dental, and vision insurance coverage * 401(k) retirement plan with employer match * Paid vacation and sick leave * Opportunity to work in a highly specialized diagnostic manufacturing environment * Career growth opportunities within Werfen North America

Citybuzz
Sep 9th, 2025
VolitionRx Partners with Werfen to Advance Diagnostic Testing for Antiphospholipid Syndrome

VolitionRx partners with Werfen to advance diagnostic testing for antiphospholipid syndrome.

The Bedford Citizen
Dec 11th, 2024
Werfen Opens New Building for Innovation at U.S. Technology Center on Hartwell Road

Werfen opens new building for innovation at U.S. Technology Center on Hartwell Road.

The Business Journals
Dec 3rd, 2024
Werfen to hire 'hundreds' in next few years as it expands in Bedford

Werfen to hire 'hundreds' in next few years as it expands in Bedford.

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