04 ene
Buscojobs México
Ciudad Juárez
**BEAVER VISITEC (INDUSTRIA MEDICA)**
**Solicita**:Sr. Advanced Manufacturing Engineer ( Tech transfer leader )**
**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 Advanced Manufacturing Engineer (AME) serves as the leader for operations on new product development and introduction projects leading activities ranging from process design and development through manufacturing launch planning and execution.
In the short term, this role will specifically be the project leader for a technology transfer project from a prototype line to a contract manufacturer (CMO) for a complex electro-mechanical, digital optics disposible device.
The Sr.
Engineer is responsible for leading the leading the prototype site and CMO engineers through the activities of project planning and timeline management, process re-design and development as required, capital equipment and tooling design and development, and process validation activities, among other operations deliverables as required to ensure the transfer is completely quickly, with optimized product costs, and with reliable manufacturing processes.
In the longer term, this role will support the Juarez, MX AME team working on tech transfers, and support lifecycle management projects related to improvements to manufacturing processes to improve quality, capacity, costs, and other related operational elements.
**RESPONSIBILITIES***:
- Project and team leader for technology transfer project
- Developing project plans and timelines for technology transfer projects
- Contribute to contract manufacturer evaluation and selection.
- Accountable for process design (including equipment and tooling), development, and validation (IQ/OQ/PQ) and capital/capacity planning at a contract manufacturer site
- Remotely directing contract manufacturer resources to execute relevant tasks.
- Oversees design controls operations related documentation such as plans/protocols/reports,
test methods, work instructions, PFMEAs, control plans, and contributes operations content to global regulatory submissions
Partnering with R&D; to ensure that manufacturing infrastructure supports product design and overall project and business needs.
- Design and conducting process studies to evaluate opportunities for improvements to the manufacturing process.
- Identifying opportunities to improve manufacturing quality, capacity, and cost elements within existing product manufacturing processes
- This role will initially focus on the technology transfer of a electro-mechanical, digital optics disposable device
- In the longer term, this role will focus typically on high volume, mechanical, sterile, disposable products manufactured in BVI's Juarez, MX manufacturing facility.
- Mentoring and developing junior engineers to ensure talent is enhanced, grown, and retained
- Other duties as required
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES***:
- Strong understanding of ISO 13485, ISO 14971, FDA CFR part 820
- Business-level fluency in English and Spanish
- Excellent analytical skills (effectively supports decisions on factual data and analysis).
Ability to make informed decisions on limited or imperfect data
- Strong project management skills - able to manage timelines, project risks, and competing priorities from various functional inputs.
- Process design and development expertise - specifically for electromechanical disposables, miniature components
- Strong engineering problem solving skills
- Knowledge of electronic, electromechanical and digital optics assembly
- Ability to work internationally and remotely - understands and adapts approach to regional norms to build relationships and drive success through face to face and remote interaction.
- Ability to adjust and cater message clearly in a variety of circumstances (e.g.
executive, within function, cross function, customer, supplier, international)
- Ability to evaluate, triage, and mitigate risks, both product and project.
Ability to influence a highly decentralized organization without direct authority
- Ability to analyze and evaluate opportunities in manufacturing to improve product cost structures.
- Comfort and courage to operate in new areas of the business with limited direction.
A willingness to try, fail, and try again
***
**MINIMUM REQUIRED EDU
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.