Full-Time

Senior Program Manager-R&D

Medical Device

Deadline 3/9/27
Werfen

Werfen

1,001-5,000 employees

Global specialized diagnostics provider

Compensation Overview

$190k - $220k/yr

+ Performance-based bonus

Bedford, MA, USA

In Person

Category
Biology & Biotech (1)
Business & Strategy (1)
Required Skills
Agile
Risk Management
Requirements
  • BS in STEM or management discipline of MS/MBA
  • Additional course work in accounting, business economics, strategy development, resource management and project management is desired
  • At least 10 years of experience, preferably in product development with at least 5 years of successful technical leadership, project coordination, or project management are required
  • Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable
  • Certification in program management is preferred
  • Full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing introduction
Responsibilities
  • Provide technical and team leadership to one or more large project team(s) or program team(s). This may include directly leading one of the projects.
  • Leadership entails planning, scheduling, assignment of work, and technical support within the program area. Drive the successful attainment of program goals.
  • Responsible for project or program planning and scheduling, clarifying and defining the scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates.
  • Generates integrated project plans that meet business objectives and are in compliance with the design control process, while maximizing resource efficiency.
  • Responsible for conducting regular project or program team status meetings and reviews.
  • Ensures deliverables are completed and documented.
  • Identifies the need for and implements changes to the program and project plans that are within approved program and project boundaries.
  • Plan and conduct major program and supporting project and milestone reviews.
  • Participates in the decision-making process regarding when to employ the Agile methodology. Ensure adequate resources are applied to Agile projects.
  • Responsible for coordination of program and project resources to identify the root cause(s) of program and project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion.
  • Responsible for ensuring program and project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are included within the program and project plan.
  • Regularly assess and report the status of overall program risk remaining on a program.
  • Identify risk trends and patterns across the program and develop risk mitigation strategies for systemic risks.
  • Creates and maintains file to current phase ensuring accuracy. Ensure compliance with Design Control practices.
  • Responsible for program communication for both within the project team(s) and between the team(s) and executive management.
  • Responsible for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project.
  • Responsible to establish communication channels with commercial functions, support team and infrastructure to ensure successful on market change(s) and/or new product introduction.
  • Uses input from commercial functions to influence and execute program plan.
  • Able to resolve program and project team conflict through the application of good listening skills and negotiating skills.
  • Able to remove oneself from the problem. Fosters a creative, professional climate that will maximize the contributions of the technical staff.
  • Ensures that adequate equipment and material resources are available to advance the program and project(s) and achieve goals and objectives.
  • Works with other program and project managers to ensure the best use of shared resources.
  • Demonstrated functional management expertise and skills in developing, mentoring and coaching others. Works with functional management participating in skills/gap assessments and conducting coaching for project core team members.
  • Provides direct supervision to Program Managers and Project Managers assigned to the program.
  • Lead activities focused on improving the efficiency and effectiveness of the product development processes and procedures.
Desired Qualifications
  • Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable
  • Certification in program management is preferred

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

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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.