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Product Engineer II
3 weeks ago
Product Engineer II (Through end of January 2025 // Minneapolis, MN):
Hybrid 3 days onsite, 2 days remote
Top 3 Skills:
- Quality engineering experience and/or education (following quality processes, ensuring quality in work outputs)
- Packaging engineering experience and/or education (final pack configurations design)
- Must be confident using Excel, Word, SharePoint/OneDrive/Teams
Primary Responsibilities:
- Support for final pack configuration design and new end item configuration setup
- Release support (Product Release checklists, authorizations) for physical products and software
- Support ad hoc requests related to end items and product release
Target Years of Experience:
- At least two years of work experience within a regulated environment, ideally Medical Devices, but will consider internship experience as well
Description:
The Release Engineer II works under general supervision to provide global product release support and guidance to execute the release of design for release product engineering (RPE) programs. Provides support, as needed, to execute the release of design for new product introduction (NPI) programs.
Duties:
- Analyzes, troubleshoots, and provides technical skills to RPE programs. Provides support, as needed, to NPI programs.
- Participates in the planning and coordination of engineering projects, generating project-level documentation as appropriate.
- Monitors projects and participates in improving operating efficiency.
- Generates and completes plans and reports or other documentation in compliance with applicable Medtronic procedures.
- Provide work direction and guidance of strategy and execution to cross-functional partners in the area of product release.
- Provide technical operating unit knowledge and project direction to global cross-business teams supporting common process and systems.
- Supports the development and approach to solutions for meeting business objectives for product release.
- Supports the liaison of cross-functional alignment in the areas of Configuration Management, Development, and related Operations functions.
- Supports defining the direction for new products, processes, standards, or operational plans by developing and implementing solutions to complex problems.
- Responsible for production support engineering with respect to technical feasibility of product configurations
- Assumes oversight for device and/or internally produced or externally purchased components for specified product portfolios
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; and optimizing device production relative to cost constraints.
- Assumes responsibility for device after transfer into high volume production and usually responsible for entire device manufacturing operations other than wafer fabrication.
- May assist customer in device usage problems or customer testing of complex devices.
Must Haves
- Bachelor’s degree (engineering or technical) with 2+ years of job-related experience, OR
- Master’s degree (engineering or technical) with 6+ months of job-related experience
Nice to Haves
- Experience working in a regulated environment.
- Experience working in a medical device environment.
- Experience working with FDA, ISO, EN, and/or GMP standards.
- Proven, strong detail-oriented work skills.
- Proven ability to easily adapt to multi-task and shift priorities effectively and expediently.
- Proficiency with common software packages (e.g., Word, Excel, Adobe Reader).
- Demonstrated ability to work independently and with a team.
- Demonstrated involvement in process definition and improvement.
- Formal training in Product Data or Lifecycle Management systems.
- Ability to learn and adapt to changes in technology, processes, or requirements.
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