12 ene
Empresa líder
Ciudad Juárez
**BEAVER VISITEC (INDUSTRIA MEDICA)**
**Solicita**:Sr. External Manufacturing Engineer**
**Descripción y Requisitos**
COMPANY OVERVIEW:
BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments),
Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).
PURPOSE:
The Senior External Manufacturing Engineer, will have two primary purposes:
- The Senior External Manufacturing Engineer will lead the EUMDR project plan activities in accordance to the EUMDR project management team. You will work directly with external partners to ensure they are compliant to EUMDR requirements and lead efforts to remediate and meet agreed upon timelines.
- The Senior External Manufacturing Engineer will lead highly visible projects related to strategic plans, plant and portfolio transfers, capacity expansion, product quality, cost & performance objectives. You will be responsible to ensure external manufactures deliver results and drive accountability. This role will interact with strategic contract manufacturers and OEMs around the world.
RESPONSIBILITIES:
- Lead EUMDR initiatives with external partners to ensure compliance to EUMDR requirements and timelines per the agreed upon timeline.
- Lead complex projects focusing on plant and portfolio transfers.
- Lead and or organize plant performance reviews for external manufacturers.
- Ensure product is properly designed for manufacture & manufacturers are properly selected & qualified.
- Interface with manufacturers & internal stakeholders to ensure design for manufacturability, quality & cost team goals are met.
- Assist by providing technical support to evaluate & select manufacturers.
- Provide technical support to assist in establishing & maintaining GMP compliant processes.
- Perform engineering studies & analyses on existing manufacturing processes to improve process reliability, problem solve, or to improve product quality & cost.
- Design & / or purchase tooling & equipment. Using appropriate statistical techniques develop validation protocols,
complete process capability studies & process validation on both internal & supplier processes.
- Take an active role in learning for self & others to further company objectives.
- Complete assignments involving a specific phase of an engineering project & / or line support activity.
- Provide line support responsibilities for specific products.
- Coordinate technical & or business issues with internal & external customers.
Plan, conduct & direct engineering / business projects to completion.
- Coordinate & direct activities of other technical support staff & delegate their assignments as required.
Plan, conduct & direct technical / business projects to completion (typical scope is at External Manufacturing or Operations level).
- Devise or adapt new methods, using a full understanding of procedures & various product support improvement techniques.
- Participate in all other team activities contributing where required to other functional areas within team.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Excellent understanding of ISO 13485, ISO 14971, FDA CFR part 820.
- Excellent business-level fluency in English and Spanish.
- Experience with process validation, statistical process control & knowledge in Applied statistics is preferred.
- Strong project management experience and capabilities.
- Strong Process design and development expertise.
- Strong engineering problem solving skills.
- Proven ability to work internationally - understands and adapts approach to regional norms to build relationships and drive success.
- Proven ability to adjust and cater message clearly in a variety of circumstances (e.g. executive, function, cross function, customer, supplier,
international).
- Demonstrated ability to evaluate, triage, and mitigate risks, both product and project. Ability to influence a highly decentralized organization without direct authority.
- Comfort and courage to operate in new areas of the business with limited direction. A willingness to try, fail, and try again.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Experience working in a highly regulated industry (medical strongly preferred).
- Fluid in English and Spanish.
PHYSICAL REQUIREMENTS
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- Inter
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