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Senior Engineer, Manufacturing - Hardware (ViPid)

Job Description

JOB SUMMARY

Think Surgical Inc, the developer of the surgical assistant, is looking for a seasoned manufacturing engineer to lead and manage release of new medical devices into production.

DUTIES & RESPONSIBILITIES

  • Takes ownership of activities for new product development during engineering design and pilot production stages to ensure a successful and sustained product launch.
  • Proactively develops new product introduction plans and schedules. Escalates and resolves design, manufacturability, quality, and supply chain issues.
  • Generates workflow process diagrams, manufacturing, and maintenance plans.
  • Bears responsibility for development of detailed work instructions, procedures, checklists, travelers, and MPIs for new designs.
  • Develops floor and line layout proposals for build capacity, quality, time optimization and effective inventory management.
  • Participates in BOM management, technical specification reviews, new part requisition. Initiates Change Orders (CO) for release to production of various manufacturing documentation and supports document control in COs implementation.
  • Complete process failure mode and analysis (PFMEA). Develops and validates critical tests used in production workflow to minimize risk.
  • Responsible for the activities of validation and qualification of manufacturing equipment and processes utilizing standard qualification approaches (IQ/OQ/PQ). Manages development and delivery of completed validation plans, studies, and reports.
  • Provides feedback for product and process DFM improvements to Engineering to ensure optimal manufacturability and serviceability.
  • Responsible for maintaining compliance with medical device quality system requirements and FDA regulations.
  • Provides technical support in analyzing and/or performing investigation for discrepant production components, assemblies, and field returns.
  • Develops and updates procedures in order to consolidate new and existing product support.
  • Participates in decision making for high dollar amount orders. Leads initiatives focused on cost reduction, effective vendor selection and management, outsourcing of subassemblies, etc.
  • Visit, evaluate, and collaborate with vendors to ensure high quality & timely delivery of services.
  • Assists with assembly, testing, and troubleshooting of electromechanical assemblies.
  • Provides leadership, training, and technical support to production technicians.
  • Implements fixtures to aid in production.
  • Other duties or special projects as required in order to meet company s objectives.

Qualifications

Required Qualifications

  • Minimum a four-year degree (Bachelor s) in industrial or mechanical engineering or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2016 or in a highly regulated manufacturing environment.
  • Need a minimum of 5 years of experience in manufacturing engineering of complex electromechanical devices. Experience with IEC60601-1 compliant devices is preferred.
  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
  • Experience with six sigma, 5S, GD&T is preferred.
  • Experience using an ERP and PLM system, such as Epicor, Arena or similar.

Strong technical skills in prototyping and troubleshooting using engineering documentation.

  • Must be able to read and understand assembly drawings, BOMs, workflow diagrams, MPIs, identify components and read basic schematics.
  • Possess skills and aptitude to lead projects, effectively manage multiple tasks in a timely manner, and coordinate work with others is highly desirable.
  • Experience in writing, reading, and interpreting the documentation of designs and production processes. Able to define instructions that are moderately complex in nature.
  • Good written and verbal communication skills with all levels of employees, suppliers, and customers.

Preferred Qualifications

  • Knowledgeable using SolidWorks 2017 or higher (assembly, sheet metal, 3D modeling and drawings) for fixture design work.
  • Experience using Arena, Jira, Confluence, and Jama software in a collaborative environment
  • Understanding of tolerance stack up
  • OSHA training

COMPETENCIES

  • Creating effective production workflow and configuration management process for large medical device equipment and accessories.

Effective people skills.

PHYSICAL DEMANDS & WORK ENVIRONMENT

  • Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
  • Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 30 lbs.
  • Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
  • Occasionally work around moving electro-mechanical parts.
  • Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
  • Must be able to travel as business necessitates (up to 20%).

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management s right to assign or reassign duties and responsibilities to this job at any time.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Senior Engineer, Manufacturing - Hardware (ViPid)

Thinksurgical
Fremont, CA
Full Time

Published on 01/13/2022

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