Please send us your CV by email, stating the position you are applying to: info@beyeonics.com
OPEN POSITIONS:
1. QA Specialist
Job description
- Responsible for the document control process including maintenance of quality records and documents including Validation Reports, Design History files, Manufacturing Transfer Records, and Risk Management files
- Review documents for accuracy, completeness, and compliance
- Manage the flow of documentation within the organization and monitor status of in-process document changes to ensure timely revisions
- Performs self-audits of DMR locations and ensures that the current revision is available and in use.
- Investigates and responds to corrective actions related to Document Control, Training, and External Standards.
- Coordinates and facilitate Engineering Change Request process.
- Facilitate the complaint handling process, which includes reviewing all customer complaints, liaising with Regulatory for assessment, assigning a complaint investigator, and ensuring all complaints are properly investigated, documented, and resolved in a timely manner.
- Compile, analyze, track and report customer complaint data.
- Support engineers with complaint investigations as needed.
- Reporting to the QA / RA Manager.
Required qualifications
- Engineering Bachelor’s Degree, Bio Medical is preferred.
- English proficiency at very high level.
- Practical experience of 3-5 years of Quality Assurance experience in medical devices (multi-disciplinary device experience strongly preferred)
- Working knowledge of relevant regulations and standards (e.g. ISO 13485, 21 CFR 820, MDR, ISO 14971)
- Experience working on multiple projects with aggressive timelines
- Must have proven skills to perform tasks accurately.
- Eye for detail and accuracy.
- Read, understand and interpret documents such as operating procedures, safety rules, design specifications, operating and maintenance instructions and technical procedure manuals.
- Strong troubleshooting skills to assist with defining problems, collection of data, establishment of facts and drawing valid conclusions.
2. NPI – Engineer
Job description
We are looking for an engineer to Lead our NPI activity, Primarily in New product introduction and transfer from R&D to our production. In this position you will be responsible for insuring Design for manufacturability is considered at all stages of product development and assume responsibility for various engineering aspects in production.
- DFx methodology implementation (Design for manufacturability , test, cost, serviceability etc.) to insure Risks are mitigated at the Design level , working with R&D and manufacturing from initial production process planning stages, to the manufacturing of prototypes and initial production of First serial production.
- Writing work procedures and instructions, training certifying and technically guiding the Production team.
- Implement ECO’s post design freeze leading to and through full scale-production.
- Preparing Product Specifications and technical documentation.
- Troubleshooting manufacturing problems (NCR / MRB), investigating production failures and perform root causes analysis.
- Develop production processes, Design, qualify, document and validate: assembly & test fixtures/Jigs and tools
- Configuration management: Datasets setup, BOM creation DEG update and Component Engineering.
- Technical POC for subcontractors (electronics, plastics and metals)
- Initiate Cost reduction and production streamlining.
- Perform Other operations related tasks from time to time as directed.
Required qualifications
- BSc.in Mechanical Engineering or similar technical background
- 4+ years of experience in transfer from development to production, Hands on engineering experience in manufacturing engineering , PCBA, Device assembly and mechanical components (Machined parts , plastic mold injections, casting.)
- 2+ years of experience in design Engineering & manufacturing environments of multi-disciplinary products in Medical Device
- Experience with process optimization/improvement, lean manufacturing, 5S, Root cause analysis & CAPA.
- Experience with Solidworks and ERP, PLM ( Priority is an advantage )
- Exceptional written communication skills in English
3. Technical project manager
Job description
We are looking for a talented and motivated manager to lead the development of a new electro-optic product:
- Lead a multidisciplinary team of system, electro-optics, mechanical, SW, HW, and algorithm engineers
- Manage and set detailed work-plans for the team
- Be responsible for the team’s deliverables
- Lead system architecture decisions
- Lead problem solving to meet execution goals
- Assist engineers with solutions, technical decisions and tradeoffs in fields of expertise
- Provide weekly updates on progress and plans to R&D manager and PM
Required qualifications
- Proven successful record in managing multidisciplinary teams including SW, system engineering, Algo, mechanical, and HW
- Proven successful record in managing development of electro-optical products
- Strong technical background in systems engineering and electro-optics
- Experience in the medical device industry – an advantage
4. Technical project manager – Software applications
Job description
We are looking for a talented and motivated manager to lead the development of software applications to improve surgical outcomes:
- Lead a team of software and algorithm engineers
- Manage and set detailed work-plans for the team
- Be responsible for the team’s deliverables
- Lead system architecture decisions
- Lead problem solving to meet execution goals
- Assist engineers with solutions, technical decisions and tradeoffs in fields of expertise
- Provide weekly updates on progress and plans to R&D manager and PM
Required qualifications
- Proven successful record in managing software and algorithm teams
- Proven successful record in managing the development of software products based on image processing/computer vision/machine learning
- Strong technical background in either software or algorithm development
- Experience in the medical device industry – an advantage
5. Electro-optics systems engineer
Job description
We are looking for talented and motivated systems engineers for the development of our products:
- Be a part of a multidisciplinary team of system, electro-optics, mechanical, SW, HW, and algorithm engineers
- Lead the development of electro-optical modules
- Drive product performance improvements
- Engage with other team members to develop the product requirements, test and integrate their deliverables
- Participate in system architecture decisions
Required qualifications
- Proven successful record in electro-optic systems design or equivalent record from academia (MSc, PhD)
- Strong technical background in electro-optics
- Experience with multidisciplinary projects – an advantage
- Experience in the medical device industry – an advantage