Lead Manufacturing Engineer

4 weeks ago

Bedford, Bedford, United Kingdom Werfen Full time

Overview

Werfen

Werfen is a dynamic, family-owned enterprise based in Barcelona, Spain, recognized globally for its expertise in specialized diagnostics, particularly in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplantation. Our Original Equipment Manufacturing (OEM) division focuses on the research, development, and production of tailored assays and biomaterials. We operate in 30 countries and collaborate with distributors in numerous other regions. Our Headquarters and Technology Centers are situated in the US and Europe, employing over 7,000 professionals.

Our achievements stem from a dedicated focus on these rapidly advancing diagnostic fields, unwavering commitment to our clients, and a strong emphasis on innovation and quality. We are devoted to equipping healthcare professionals with comprehensive solutions that enhance hospital efficiency and improve patient outcomes.

Job Summary

The position entails a blend of Senior Engineering and Project Management responsibilities. As a Senior Manufacturing Engineer, you will leverage advanced engineering principles to support a wide array of Manufacturing Engineering activities. This includes addressing complex challenges related to product design and manufacturing processes, enhancing existing processes, and facilitating daily production operations. In the capacity of Project Manager, you will orchestrate multi-functional product enhancement initiatives, oversee product transfer projects, and drive continuous improvement efforts within a larger Global program.

This role demands robust leadership capabilities in a highly technical medical instrument setting, alongside regular collaboration with scientists, hardware and software engineers, technicians, marketing/sales teams, quality assurance, manufacturing personnel, suppliers, administrative staff, and senior management. You will need the confidence to guide skilled technical engineers and scientists in a vibrant and interactive work environment, steering the project team towards achieving the anticipated business outcomes.

Responsibilities

Key Accountabilities

**Technical Leadership:** Provide guidance and technical leadership to cross-functional project teams, ensuring design specifications are met and adhere to relevant standards. **Problem Solving Leadership:** Coordinate technical resources to identify the root causes of project challenges and develop actionable plans to resolve, test, and implement effective solutions. **Risk Management:** Ensure that both technical and management risks are identified and addressed within the project framework, developing risk mitigation strategies as necessary. **Project Planning and Scheduling:** Lead project planning and scheduling efforts, defining the scope of work and project specifications, while utilizing milestone methods and critical path scheduling to meet business objectives. **Process Control Development:** Create and implement process controls for product transfers to manufacturing or new manufacturing sites. **Project Execution and Oversight:** Conduct regular project team meetings and reviews, overseeing validation project teams and ensuring all deliverables are completed and documented. **Design Control:** Author, review, and approve validation protocols, Standard Operating Procedures (SOPs), and technical reports for new products and processes. **Regulatory Compliance:** Ensure all projects adhere to FDA regulations, Good Manufacturing Practices (GMP), Quality System Requirements (QSR), ISO standards, and other applicable guidelines. **Continuous Improvement:** Identify and implement opportunities for ongoing improvement in processes and practices. **Communication:** Maintain clear communication regarding project status with both the project team and executive management. **Resource Management:** Ensure that necessary equipment and materials are available to support project advancement and achieve set goals. **Conflict Resolution:** Utilize effective listening and negotiation skills to resolve conflicts within the project team.

Qualifications

Minimum Knowledge & Experience for the position:

Bachelor's degree in engineering; advanced degree preferred. A minimum of eight years of experience in manufacturing engineering is preferred. Experience in a regulated medical device or pharmaceutical environment is essential. Comprehensive knowledge of the entire product lifecycle, from conception through to manufacturing introduction, is required. Proven experience in the successful launch of at least one medical instrumentation product is desirable. A minimum of three years in technical leadership, project coordination, or project management is required.

Skills & Capabilities:

Six Sigma Green Belt or Black Belt certification is a plus. Extensive experience in process and product manufacturing is essential. Proficiency in interpreting engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs). In-depth experience with automation development to suggest design enhancements. Expertise in writing and executing validations in a regulated environment. Familiarity with statistical sampling and analysis techniques. Understanding of FDA regulations, GMP, ISO standards, and OSHA regulations; experience with regulatory audits is preferred. Excellent written and verbal communication skills are required. Strong troubleshooting skills for equipment failures are necessary. Proficient in MS Office; knowledge of statistical software and large enterprise resource planning (ERP) systems is preferred. Exceptional organizational and time management skills, with a keen attention to detail.

Travel Requirements:

Approximately 20% travel may be required, including international mobility.

Werfen is an Equal Opportunity employer committed to fostering a diverse workplace. We strictly prohibit any form of unlawful discrimination, harassment, or retaliation based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable law.

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