48 Senior Director AME Jobs in Waltham, MA
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Senior Director AME
$188k-233k (estimate)
Full Time | Medical Technology
2 Months Ago
Sorry! This job is no longer available. Please explore similar jobs listed on the left.
BVI Medical is Hiring a Senior Director AME Near Waltham, MA
Purpose Leads global manufacturing strategies for new manufacturing processes and technologies. This role will drive best in class performance, process, and cost optimization by overseeing for BVI:
- Plant network strategy including site/partner selection, technical transfers and make/buy decisions.
- New Product transfers into internal and/or external plant network
- Overall Operational Excellence program portfolio including capital investments and the introduction of new manufacturing technologies
- Reports to the SVP, Global Operations & Technology.
- Coaching, developing, and leading the technical organization leveraging expertise in Medical devices systems and New technology. Promote a culture of high performance, engaged talent and continuous improvement.
- Oversees documentation such as Plans/Protocols/Reports, Test Methods, Work Instructions, PFMEAs, CAPAs/NCMRs, and Regulatory submissions. Working knowledge of key Medical standards such as FDA CFR Part 820 and ISO 13485. Understand medical device requirements as it relates to Risk Management, Validation, Statistical Process, and Production Control.
- Managing project portfolio, project execution from inception to completion, with a focus on manufacturing, equipment optimization and technology enhancements including automation.
- Acting as the liaison between key departments per project requirements: QA/regulatory, product development and manufacturing. Effectively utilizing team leadership and facilitation skills to drive business outcomes.
- Working effectively in a matrix environment with global decentralized resources. Collaborating with (internal and CMO/external) engineering and product development groups on key New Product Introduction initiatives and enabling Design transfer into industrialization.
- Supporting new Plant Network initiatives including, but not be limited to: technical transfers, operational excellence program, new equipment and technology, human capital requirements, floor space and facility layouts, other key projects as needed.
- Manage global capital investments for plant network including appropriate risk analysis and prioritization.
- Minimum of seven (7-10) years direct experience in Project Management within a manufacturing environment; Experience in Medical Devices required.
- Bachelors Science Degree in Engineering degree required with a focus in mechanical, industrial, or manufacturing engineering
- Demonstrated ability to develop business, operational and financial strategies, plans and programs that support organizational objectives.
- Ability to translate broad strategies into specific objectives and action plans.
- Knowledgeable in manufacturing best practices, machine utilization, capacity management and equipment standards
- Certifications in Lean, 6 sigma and Project management are strong plus.
- Leadership and influence to drive organizational strategy around new technology and special projects.
- Hands-on and solution driven. Strong financial, analytical, and problem-solving skills. Creative ability to “think-outside-the-box”.
- Software application knowledge and proficiency in MS Excel
- Excellent oral and written communication skills
- Travel up to 25%.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$188k-233k (estimate)
POST DATE
05/27/2024
EXPIRATION DATE
06/28/2024
WEBSITE
bvimedical.com
HEADQUARTERS
WALTHAM, MA
SIZE
500 - 1,000
FOUNDED
2010
CEO
DANA G MEAD JR
REVENUE
$50M - $200M
INDUSTRY
Medical Technology
Related Companies
About BVI Medical
With nine decades of delivering high quality solutions and innovation to advance eye surgery, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our Company aspires to be the most trusted and valued partner to our customers worldwide. Our trusted brands include: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products), PhysIOL (Premium Intraocular Lenses), Endo Optiks and CustomEyes (Custom Surgical Packs). BVI provides innovative and high quality products supporting ophthalmic s...urgeons and their patient outcomes. Learn more at bvimedical.com.
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