Title: BIFG MANUFACTURING ENGINEER
[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 and/or support 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 to achieve required business operational control and agreed service levels regarding Contract Manufacturers (CM)
- Deliver technical and engineering solutions to the business regarding the process at CM
- Collaborate with BIFG 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 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 manufacturing or production engineering environment.
- Minimum of 3-year experience in medical devices with strong preference in wound dressings.
- 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.