Title: SENIOR MANUFACTURING ENGINEER (BIFG)
[MANUFACTURING ENGINEER FOR EXTRNAL MANFUACTERS]
Purpose of Job:
Oversight of the technical management of external contract manufacturing partner(s). Deliver engineering solutions to the business regarding external contract manufacturers. Lead engineering projects including process validation, continuous improvement, manufacturing transfer or COGS for Bought-in-Finished-Goods (BIFG).
Major Duties and Primary Responsibilities:
- Partner with BIFG and Quality team members to achieve required business operational control and agreed service levels regarding Contract Manufacturers (CM)
- Lead & Deliver technical and engineering solutions to the business regarding the process at CM
- Collaborate with BIFG team to support product availability from CM against build commitment & schedule
- Plan, facilitate and execute engineering projects with CM to drive effective cost structures and control.
- Provide engineering oversight of change control on technical matters, such as process validation and manufacturing transfer……etc., within CM
- Lead, coordinate and execute manufacturing transfer of projects on the new product development or/and design change of sustaining products.
- Actively manage the portfolio of engineering projects within CM
- Actively manage technical issues within CM using structured methodologies
- Facilitate and drive continuous improvement with CM in terms of product quality and service.
- Exercise project management discipline on technical projects as appropriate in achieving business objectives.
- Partner with BIFG team in initiating & driving product cost reduction and continuous improvement strategies with suppliers.
- Provide technical oversight, support and guidance to CM on process development, test method validation (TMV)and process validation, design for manufacture (DFM).
- Review and approve supplier change requests and Acelity initiated change requests.
- Monitor and control progress of supplier engineering projects, ensure sound application of engineering practices and provide project reviews where necessary.
- Follow strict adherence to the requirements of CGMP.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
- Participates in the assessment of feasibility, selection and application of proposed technology initiatives related to CM.
- Provide technical information on appropriate areas to all functions within the business.
- Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
- Manage Acelity owned assets at CM sites to ensure appropriate maintenance and obsolescence planning is deployed
- Conforms to, supports, and enforces all Company policies and procedures.
- Bachelors Degree in Biomedical, Materials Engineering, Chemical Engineering, Mechanical Engineering or relevant technical discipline.
- Minimum 5-year experience in a regulated manufacturing or production engineering environment.
- Minimum of 3-year experience in medical devices with strong preference in wound dressings.
- Demonstrated experience in leading projects to successful completion
- Demonstrated understanding of cGMP, Design Control & Validation practices, problem solving and expectations.
- Demonstrated experience in manufacturing transfer and project management.
- Language skill in Spanish a plus.
- Experience of product design a plus.
- Flexibility around with working hours and travel.
- Demonstrated competency in MS Access, Excel, Oracle/SAP/ERP & query development.
- Ability to interpret engineering drawings/specifications/familiarity with inspection techniques.
- Excellent interpersonal & communication skills
- Strong leadership, decision-making & problem solving skills.
- Process Excellence qualification or training or knowledge of principles; competency in Six Sigma, practicing Green Belt a plus.