Senior Manufacturing & Project Engineer Operational Excellence
Company: Werfen
Location: Bedford
Posted on: October 16, 2024
Job Description:
OverviewWerfen Werfen is a growing, family-owned, innovative
company founded in 1966 in Barcelona, Spain. We are a worldwide
leader in specialized diagnostics in the areas of Hemostasis, Acute
Care Diagnostics, Transfusion, Autoimmunity, and Transplant.
Through our Original Equipment Manufacturing (OEM) business line,
we research, develop, and manufacture customized assays and
biomaterials. We operate directly in 30 countries, and in more than
100 territories through distributors. Our Headquarters and
Technology Centers are located in the US and Europe, and our
workforce is more than 7,000 strong. 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. Job SummaryThis role requires
a combination of Senior Engineer & Project Manager
accountabilities, responsibilities, and capabilities. As a Sr.
Manufacturing Engineer, one will apply advanced knowledge of
engineering principles and analyses to support a complex range of
Manufacturing Engineering activities, including solving
multifaceted issues related to product design and manufacturing
processes, new and existing processes, product improvement, and
supporting daily production operations. As a Project Manager, one
will plan and manage multi-functional product improvement efforts,
product transfer projects, continuous improvement, and/or several
sub-projects within a large, Global program. The position requires
strong leadership skills in a highly technical medical instrument
environment, as well as regular interaction with scientists,
hardware engineers, software engineers, technicians,
marketing/sales, quality, manufacturing, suppliers, administrative
personnel, and senior management. Requires confidence to lead
strong technical engineers and scientists in a dynamic,
interactive, and energetic workplace. Directs the project team in a
manner to achieve the business results expected.
ResponsibilitiesKey Accountabilities
- Technical Leadership: Provide technical and team leadership to
one or more cross-functional project teams, ensure design
requirements are met and comply with applicable standards.
- Problem Solving Leadership: Responsible for coordination of
technical resources to identify the root cause of any project
issue, and develop and manage a plan to fix, test, and implement an
appropriate solution through completion.
- Risk Management: Responsible for ensuring project risks, both
technical risks and management risks, are identified and
appropriately addressed within the project plan. Develop risk
mitigation plans.
- Project Planning and Scheduling: Work as a lead project team
member to complete all activities needed to conclude projects per
plans. Responsible for project planning and scheduling, clarifying
and defining scope of work and project specifications. Utilize
deliverable milestone methods and critical path scheduling,
conducting resource planning and allocation, and developing tasks
to meet business objectives.
- Develop and implement process controls for product transfer to
manufacturing, or to new manufacturing site.
- Project Execution and Control: Responsible for conducting
regular project team status meetings and reviews. Oversee
validation project teams; prepare agendas, issue meeting minutes,
and participate in development of quality plans. Ensures
deliverables are completed and documented.
- Design Control: Write, review, and approve validations
(installation qualification IQ/operational qualification
OQ/performance qualification PQ protocols, Standard Operating
Procedures (SOP), technical reports and final reports) for new
products, processes, and equipment.
- Ensure all projects/processes are following FDA, Good
Manufacturing Practices (GMP), Quality System Requirement (QSR),
ISO-13485:2003 and other applicable requirements.
- Identify and implement opportunities for continuous
improvement.
- Communication: Responsible for project communication to both
the project team and executive management.
- Resource Allocation: Ensures that adequate equipment and
material resources are available to advance the project and achieve
goals and objectives.
- Conflict Resolution: Able to resolve project team conflict
through the application of good listening skills and negotiating
skills. QualificationsMinimum Knowledge & Experience for the
position:
- Bachelor's degree in engineering; advanced degree a plus.
- Eight (8) years previous manufacturing engineering experience
preferred.
- Previous experience within a regulated medical device or
pharmaceutical environment
- Requires full and comprehensive knowledge of the complete
product lifecycle, including all aspects of product development
from conception to manufacturing introduction.
- Experience in the development and release of at least one
successful product launch of a medical instrumentation product is
desirable.
- Product development experience, including three years in
successful technical leadership, project coordination, or project
management are required. Skills & Capabilities:
- Six sigma green belt or black belt methodology a plus.
- Extensive knowledge/experience in process and product
manufacturing.
- Experience in creating and understanding engineering drawings,
schematics, specifications, tolerancing, and bills of materials
(BOMs).
- In-Depth experience with automation development to be able to
suggest proper design improvements.
- Expertise in writing and performing validations in a regulated
environment.
- Knowledge of statistical sampling and analysis
- Understanding of Food and Drug Administration (FDA), Good
Manufacturing Practices (GMP), ISO 9000 Standards, and Occupational
Safety and Health Administration (OSHA) regulations; previous
experience participating in regulatory audits preferred.
- Excellent written and verbal communication skills.
- Excellent equipment failures troubleshooting skills are
required.
- Working knowledge of MS Office; knowledge of statistical
software and large enterprise resource planning (ERP) system
preferred.
- Excellent organizational and time management skills; attention
to detail. Travel requirements:Approximently 20%. International
Mobility required Werfen is an Equal Opportunity employer and is
committed to a diverse workplace. Werfen strictly prohibits
unlawful discrimination, harassment or retaliation based upon an
individual's 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 state or federal law. If you have a disability and need
an accommodation in relation to the online application process,
please contact NAtalentacquisition@werfen.com for
assistance.www.werfen.com
Keywords: Werfen, Plymouth , Senior Manufacturing & Project Engineer Operational Excellence, Engineering , Bedford, Massachusetts
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