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Flex Schedule Medical Device Design Jobs in Indiana

Imh

Apply knowledge of medical device design and 3D visualization (XR and Spatial Computing) and 3D ... Maintain equipment according to timelines and schedules to ensure accurate and repeatable 3D design ...

VOLT

Medical Device Assembler

Westfield, IN · On-site

$20 - $23/hr

Schedule: 1st Shift: 6:00 AM to 2:30 PM Monday to Friday 2nd Shift: 2:30 PM to 11:00 PM Monday to ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

VOLT

Medical Device Assembler

Carmel, IN · On-site

$20 - $23/hr

Schedule: 1st Shift: 6:00 AM to 2:30 PM Monday to Friday 2nd Shift: 2:30 PM to 11:00 PM Monday to ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

BSI Group

Specifically we are seeking people with knowledge of the design and manufacture of IVD cancer and ... Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of ...

BSI Prof Serv EHS West

Specifically we are seeking people with knowledge of the design and manufacture of IVD cancer and ... Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of ...

Imh

Apply knowledge of medical device design and 3D visualization (XR and Spatial Computing) and 3D ... Maintain equipment according to timelines and schedules to ensure accurate and repeatable 3D design ...

Imh

$14.50 - $18.75/hr

Schedule: The position offers some flexibility up to 40 hours per week, with an expected commitment ... Medical Device Design and Prototyping * Computational Fluid Dynamics (CFD) and Fluid Mechanics ...

Flotec

Be Seen First

Machinist / Inspector - Medical Device Manufacturing

Avon, IN · On-site

$40K - $55K/yr

Machinist / Inspector - Medical Device Manufacturing Company Overview Flotec is an Indianapolis ... Schedule Full-time position. Day shift. On-site position in Indianapolis, Indiana. Work Location ...

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All JobsMedical Device Design JobsFlex Schedule Medical Device Design JobsFlex Schedule Medical Device Design Jobs in Indiana

Flex Schedule Medical Device Design information

What is the difference between Flex Schedule Medical Device Design vs Medical Device Quality Assurance?

AspectFlex Schedule Medical Device DesignMedical Device Quality Assurance
CredentialsEngineering degree, design certificationsQuality certifications, ISO standards
Work EnvironmentDesign labs, R&D departmentsQuality control labs, manufacturing sites
Industry UsageProduct development, innovationCompliance, testing, validation

Flex Schedule Medical Device Design focuses on creating and developing new medical devices with flexible working hours, often in design labs. Medical Device Quality Assurance emphasizes ensuring product compliance and safety, typically in quality control environments. Both roles are essential in the medical device industry but differ in their primary functions and work settings.

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Flex Schedule Medical Device Design jobs near you

Medical Device Design Control Engineer

Prophecy Technologies

Indianapolis, IN • On-site

$123K - $148K/yr

Full-time

Posted 25 days ago

Job description

Role Overview:
This role involves supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The engineer will be responsible for reviewing, updating, and maintaining critical documentation such as FMEAs, PHAs, Product Characterization, and Product Specifications, ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities:
  • Support Design History File (DHF) activities for medical device development projects.
  • Review, update, and maintain Global dFMEA documentation ensuring risks are adequately identified, analyzed, and mitigated.
  • Review, update, and maintain Global uFMEA documentation based on product use scenarios and user-related risks.
  • Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk management procedures.
  • Support creation and maintenance of product risk management files throughout the development lifecycle.
  • Prepare, review, and update Product Characterization documents to define product performance and design intent.
  • Create and maintain Product Specification Documents (PSD) ensuring alignment with design requirements and customer needs.
  • Develop and update Critical-to-Quality (CTQ) documents and establish measurable quality requirements.
  • Support development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
  • Ensure traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
  • Collaborate with Design, Quality, Regulatory, Manufacturing, and Project Management teams to support product development deliverables.
  • Participate in design reviews and provide technical input on risk management and DHF compliance.
  • Support engineering change assessments and associated documentation updates.
  • Review engineering documents for completeness, accuracy, and compliance with quality system requirements.
  • Identify gaps in documentation and recommend corrective actions.
  • Support audits, inspections, and compliance activities related to design control and risk management documentation.
  • Contribute to continuous improvement initiatives for product development and design control processes.
  • Ensure all deliverables comply with applicable regulatory, quality, and Zimmer Biomet procedures and standards.
  • Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.

Required Skills:
  • Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
  • Experience supporting DHF gap assessments, document linking, metadata management, and compliance reviews.
  • Familiarity with digital DHF structure, document hierarchy, and traceability matrix development.
  • Knowledge of DHF remediation projects and legacy design documentation migration into Cockpit Cognition.

Qualifications:
  • Experience: N/A

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