Job Information
About the Position
Introduction
Werfen
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Overview
Job Summary
Responsible for manufacturing operations for the Warren site. Provides day to day leadership and management of production, manufacturing improvements, and execution of sitewide operational excellence initiatives. Works to improve quality and ensure products ship on time. Site champion of Werfen Values, exemplifying a culture of teamwork and collaboration. Also responsible for new product transfer from R&D, including process design and process transfer. Partners with Quality counterpart to ensure both site and customer quality goals are met.
Responsibilities
Key Accountabilities
- Responsible for the on-time production of BeadChip and NGS products, including IVD, CE and RUO markets globally
- Prior production experiences with processing of silicon wafers and nano-manipulator of chips with biological functionalities is preferred.
- Monitor Absorption metrics regularly to ensure timely and cost-effective production.
- Responsible for all employees within Operations
- Promotes Werfen Values and collaboration within and across departments.
- Ensure training and competency of production personnel.
- Promotes continuous improvement mindset.
- Participate in new products transfers.
- Manage and maintain site production areas
- Participate in design of new production equipment and validation studies.
- Timely completion and installation of qualified CAPEX equipment.
- Participate in timely completion of investigation on non-conforming issue.
- Provide briefings, reports, and trending analysis to document site progress.
- Performs other duties and responsibilities as assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key Relationships
- Develops a strong working relationsip with Quality counterpart, ensuring high quality products are being built.
- Works with Supply Chain partner to ensure inventory levels are appropriate while maintaining necessary materials and components to manufacture products on time.
- Defines the overall plan for site’s success with Senior Director, Operations.
Qualifications
Minimum Knowledge & Experience required for the position:
Education: Bachelor’s degree (BS/BA) from four-year college or university; or equivalent combination of education and experience.
Experience: Minimum of 8-10 years of manufacturing experience in the medical device field or similar regulated environment.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
- Collaborative leader with a focus on developing and coaching team members and promoting a team-first mentality.
- Strong business acumen and organizational development skills.
- Strategic thinking, problem-solving, and organizational leadership.
- Excellent communication skills with executive presence.
- Energetic, forward-thinking, and creative with high ethical standards.
- Experienced in resolving conflicts and driving change.
- Passion for customer and patient focus.
Travel Requirements:
- Occasional travel to conference and operations meetings.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com