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Evening 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 ...

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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Evening Medical Device Design information

What is an evening medical device design?

An Evening Medical Device Design job involves creating, developing, and testing medical devices during evening or non-traditional work hours. Professionals in this role typically work on the design and improvement of medical equipment, collaborating with engineers, clinicians, and regulatory experts to ensure devices are safe, effective, and compliant with industry standards. This schedule can be ideal for those seeking flexibility or companies operating on extended shifts. Responsibilities may include CAD modeling, prototyping, documentation, and product testing. Evening roles are common in organizations needing round-the-clock development or support for critical healthcare projects.

What is the difference between Evening Medical Device Design vs Night Medical Device Design?

AspectEvening Medical Device DesignNight Medical Device Design
Work HoursTypically evening shifts, often from 2 PM to 10 PMPrimarily night shifts, usually from 10 PM to 6 AM
Work EnvironmentDesign labs and offices with daytime supportDesign labs with overnight team collaboration
CertificationsRelevant engineering or design certifications, FDA knowledgeSame as Evening Medical Device Design, with additional night shift safety protocols

Both roles involve designing medical devices, but the main difference lies in shift timing. Evening Medical Device Design professionals work during late afternoons and evenings, while Night Medical Device Design roles focus on overnight hours. The core skills, certifications, and industry usage are similar, with shift hours being the primary distinction.

What are some common challenges faced when working evening shifts in medical device design teams?

Working evening shifts in medical device design can present unique challenges, such as coordinating effectively with cross-functional teams who may be on daytime schedules and ensuring timely communication regarding project updates or urgent issues. Additionally, there can be fewer on-site resources or support staff available during evening hours, requiring greater independence and proactive problem-solving. However, evening shifts can also offer a quieter environment for focused design work and may provide opportunities to handle urgent tasks that arise outside of regular hours, demonstrating reliability and adaptability to managers.

What key skills and qualifications are needed to thrive as an evening medical device design engineer?

To excel in Evening Medical Device Design, you need a solid background in biomedical engineering or a related field, with expertise in device design principles and compliance with medical regulations. Familiarity with CAD software, prototyping tools, and relevant quality management systems (such as ISO 13485) is typically required. Strong problem-solving skills, attention to detail, and effective communication are crucial for collaborating with cross-functional teams and addressing design challenges. These competencies ensure the creation of safe, effective devices that meet regulatory standards and improve patient outcomes.
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 cities in Indiana are hiring for Evening Medical Device Design jobs? Cities in Indiana with the most Evening Medical Device Design job openings:
Evening 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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