Sr. Ms&T Software Engineer

MAIN JOB RESPONSIBILITIES / COMPETENCIES

Support Manufacturing in technical areas including:

1.Assess current processes and recommend improvements to the process, equipment and plant in order to drive quality and yield improvements, reduce costs and increase throughput

2.Conduct initial assessment of in-process and product failures

3.Lead and document investigations of failures of product, test equipment and test method, and validations of same

4.Liaise with R&D and other relevant partners in order to drive solutions for failures and product improvements in manufacturing

5.Review and approve process and engineering documents on behalf of Operations

6.Provide assistance in troubleshooting/resolving day-to-day manufacturing issues.

7.Create validation protocols, (process, IQ/OQ/PQ) and summarize test results as required.

8.Conduct IQ/OQ validations on new & reworked equipment.

9.Participate in design reviews and the entire Software Development Life Cycle (SDLC) to ensure activities follow design control, software development, software testing comply with applicable procedures and standards.

10. Direct Failure Mode and Effects Analysis and/or Fault Tree Analysis for software systems.

11. Develop, review, and/or approve verification and validation (V&V) protocols and reports for off-the-shelf software, configured software, custom software, and equipment with software.

12. Execute and/or manage the execution of V&V protocols.

13. Ensure Standard Operating Procedures (SOP's), Work Instructions (WI's), templates, and related Quality documents are in place and effective to comply with external regulations and standards.

14. Develop new and improve existing SOP's, WI's, and templates related to software risk management, SDLC, and V&V.

15. Adhere to SOP's and WI's to ensure compliance with internal procedures and external regulations.

16. Effectively manage multiple tasks and projects with minimal supervision.

17. Other duties as assigned.

REQUIREMENTS

EDUCATION & TRAINING

• Bachelor's degree in technical discipline or equivalent combination of education/experience.

• Master's degree in a technical discipline a plus

• Design transfer experience preferred.

EXPERIENCE

• 7 to 10 years relevant experience in medical device industry preferred.

• Knowledge of Lean Manufacturing, Six Sigma, and Project Management preferred.

• Design transfer experience preferred.

• Experience in software development lifecycle such as design documentation, process models, process decomposition diagrams, data models, data flow diagrams, entity relationship diagrams, and network diagrams.

• Experience with 21CFR Part 11 Compliance

SKILLS

• Good people skills/Interpersonal skills.

• Proficient in Microsoft Office especially in Word and Excel.

• Working knowledge of SQL

• Familiar with Automation and 21CFR Part 11 Compliance

• Process the ability to make decisions, prioritize projects, logical thinker, conceptual and creative mind.

• Demonstrated understanding of, and ability to practically implement, cGMP/QSR/ISO requirements.

• Must be able to lead teams, manage projects and complete tasks and work well with other departments.

• Excellent team building and interpersonal skills.

• Excellent prioritization, multi-tasking and organizational skills.

• Non-conformance investigations using structured problem-solving approaches.

• Process engineering.

• Communications skills at senior management levels as well as technical, quality and manufacturing operator levels, both verbal and written.

Pay range: $120k - $180k Final compensation/salary will be depend on experience

STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.