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Contract Medical Device Design Jobs in Indiana (NOW HIRING)

Imh

Apply knowledge of medical device design and 3D visualization (XR and Spatial Computing) and 3D printing technologies and associated postprocessing techniques and tools, in delivering the Advanced ...

VOLT

Medical Device Assembler

Carmel, IN · On-site

$20 - $23/hr

This is a full time, contract opportunity. Schedule: 1st Shift: 6:00 AM to 2:30 PM Monday to Friday ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

Varsity Tutors

Biomedical Engineering Tutor

Fort Wayne, IN · Remote

$18 - $40/hr

... medical device design principles while preparing students for biomedical engineering coursework ... Varsity Tutors does not contract in: Alaska, California, Colorado, Delaware, Hawaii, Maine, New ...

Varsity Tutors

Biomedical Engineering Tutor

Valparaiso, IN · Remote

$18 - $40/hr

... medical device design principles while preparing students for biomedical engineering coursework ... Varsity Tutors does not contract in: Alaska, California, Colorado, Delaware, Hawaii, Maine, New ...

BSI Prof Serv EHS West

We are seeking engineers with SaMD (Software as a Medical device) in technical capacity which can include product design, development and/or testing. Purpose of the position To build, manage, develop ...

BSI Group

We are seeking engineers with SaMD (Software as a Medical device) in technical capacity which can include product design, development and/or testing. Purpose of the position To build, manage, develop ...

Viant

Silkscreen Operator

Indianapolis, IN · On-site

$16.25 - $19.25/hr

Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With ...

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All JobsContract Medical Device Design JobsContract Medical Device Design Jobs in Indiana

Contract Medical Device Design information

What is the difference between Contract Medical Device Design vs Medical Device Design Engineer?

AspectContract Medical Device DesignMedical Device Design Engineer
CredentialsTypically requires a degree in engineering or related field; certifications like ISO 13485 are a plusRequires a degree in biomedical, mechanical, or electrical engineering; professional certifications may enhance prospects
Work EnvironmentProject-based, often freelance or consulting; varies by client and project scopeFull-time employment within a company or R&D department
Employer & Industry UsageUsed by consulting firms, contract agencies, and medical device startupsEmployed by medical device companies, hospitals, or research institutions

Contract Medical Device Design professionals focus on project-specific work, often freelance, while Medical Device Design Engineers are typically employed full-time within organizations. Both roles require similar technical credentials but differ in work setting and employment structure.

What are the most commonly searched types of Medical Device Design jobs in Indiana? The most popular types of Medical Device Design jobs in Indiana are:
What are popular job titles related to Contract Medical Device Design jobs in Indiana? For Contract Medical Device Design jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Contract Medical Device Design jobs in Indiana look for? The top searched job categories for Contract Medical Device Design jobs in Indiana are:
What cities in Indiana are hiring for Contract Medical Device Design jobs? Cities in Indiana with the most Contract Medical Device Design job openings:
Contract Medical Device Design jobs near you

Medical Device Design Control Engineer

Prophecy Technologies

Indianapolis, IN • On-site

$123K - $148K/yr

Full-time

Posted 13 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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