Job Description Summary

Apply knowledge of engineering principles and methods to ensure compliance in product and process development, validations and process optimization, line support, acceptance sampling, and continuous improvement for Class III medical devices for the Cardioband operation.

Job Description

Key Responsibilities:
• Write, review and/or approve validation protocols and reports (e.g., cleanroom, equipment, test method and product transfer validation protocols) in accordance with applicable Regulations, SOPs and Good Documentation Practices (GDP) Utilize test equipment to verify equipment parameters, process outputs or product outputs. Anticipate risks of execution and put mitigations in place so audit review requirements are met. Analyze data and perform statistical analysis to ensure validation meets predefined acceptance criteria. Work with cross-functional partners to implement comprehensive preventative maintenance work instruction as well as revalidation requirements. Write Validation Plans for projects that require multiple validations and create timeline for validation.
• Provide daily direction and guidance to manufacturing processes and personnel.

• Review and disposition Non-conformance reports where needed. Assist in Root Cause analysis in order to determine corrective and preventive action activities

• Ensure appropriate process outputs and process controls are translated into Quality Control Plans, Work Instructions and Device Records
• Evaluate risk, manage risk assessment activities and create associated documentation.
• Investigate and implement solutions to audit findings.
• Lead process improvement projects as part of life cycle approach.
• Other incidental duties assigned by Leadership

Education and Experience:
Bachelor's Degree in in Engineering or related field, at least 1 year of experience in validations within medical device or pharma industry, or related experience Required

Additional Skills:
• Basic understanding of statistical techniques.
• Manufacturing Engineering and/or Process Validation background preferred
• Proven ability to apply Engineering/Scientific theory
• Strong problem-solving, organizational, analytical and critical thinking skills
• Excellent verbal and written communication skills in English.
• Written and verbal communication skills in Hebrew
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• The Validation Engineer will need to be highly flexible and assume multiple engineering roles. As the volume of work expands in Israel, increased specialization of engineering positions will be more practical.
• This engineer will be expected to work closely with coaches and peers in Irvine, to enable the flexible nature of this job.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Required Skills

Optional Skills

.

Primary Work Location

DOM Santo Cristobal - Nave 25-Merengue

Additional Locations

Work Shift

DO Admin SH 45H 8AM-5PM (Dominican Republic)