Offer summary

Qualifications:

Master’s degree in engineering (mechanical/electrical/biomedical) with 5+ years of relevant experience or equivalent education and training., Strong engineering problem-solving skills and understanding of ISO 13485, ISO 14971, and FDA CFR part 820., Experience in a highly regulated industry, preferably medical, with knowledge of design and manufacturing of electrical wiring and connections., Ability to work internationally and adapt communication styles to various audiences..

Key responsibilities:

Lead international New Product Introduction (NPI) projects, providing technical expertise and support.

Collaborate with cross-functional teams to develop and execute optimal plans for new product development.

Introduce and validate new manufacturing technologies while overseeing design controls operations documentation.

Act as the voice of operations in the design cycle, ensuring alignment with lean manufacturing principles.

Job description

Purpose

As a Manufacturing Systems Engineer, you will lead operations for new technologies and platforms within the capital equipment division. Your responsibilities will include developing innovative solutions for manufacturing, testing, and validating cutting-edge electro-mechanical systems to achieve top-level status within the industry.

In this role within a dynamic international environment, you will collaborate with leading technical partners worldwide to make the foundations for the BVI capital equipment portfolio. Additionally, you will lead and support lifecycle management projects focused on enhancing manufacturing processes to improve quality, capacity, and cost-effectiveness.

Key Responsibilities

Lead international New Product Introduction (NPI) projects and initiatives, providing technical expertise.
Provide system engineering support for corporate projects.
Serve as a core team member for new product development, collaborating with manufacturing, supply chain, sourcing, and other operations groups to develop and execute optimal plans.
Introduce and validate new manufacturing technologies, including capital and capacity planning.
Oversee design controls operations documentation, including plans, protocols, reports, test methods, work instructions, PFMEAs, and control plans, contributing to global regulatory submissions.
Act as the voice of operations within the design cycle, conducting Design for Excellence (DfX) reviews and ensuring alignment with lean manufacturing principles.

Qualification

Required

Required Knowledge, Skills And Abilities

Fluent in English
Strong engineering problem solving skills
Understanding of ISO 13485, ISO 14971, FDA CFR part 820
Excellent analytical skills (effective support in decisions on factual data and analysis) Ability to make informed decisions on limited or imperfect data
Process design and development expertise
Ability to work internationally – understands and adapts approach to regional norms, builds relationships and drive success
Ability to adjust and cater message clearly in a variety of circumstances (e.g. executive, 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
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

Master’s degree in engineering (mechanical/electrical/biomedical) and 5+ years relevant experience or equivalent combination of education, training and experience
Experience working in a highly regulated industry (medical strongly preferred)

Minimum Required Hard Skill

Knowledge and understanding of design and manufacturing of electrical wiring and connections
Knowledge and understanding of PCBA design, manufacturing and testing
Management of electronics (multiple ECAD knowledge will be considered a plus)
Experience with prototyping development and acceptance
High level knowledge of Solid works/Solid Edge will be considered a plus

Company

BVI® is refocusing the future of vision.

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

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