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Quality Assurance Engineer II

2 months ago

Minneapolis, Minnesota, United States LanceSoft Full time

JOB DESCRIPTION
Below are additional details regarding the position from the hiring manager:

Key Skills Required:
- Experience in quality engineering or relevant education (adhering to quality protocols and ensuring high standards in deliverables)
- Background in packaging engineering or relevant education (designing final packaging configurations)
- Proficiency in using Microsoft Excel, Word, SharePoint/OneDrive/Teams

Main Responsibilities:
- Assist in the design of final packaging configurations and setup of new product configurations
- Provide release support (including product release checklists and authorizations) for both physical products and software
- Address ad hoc requests related to product configurations and releases

Supported Products:
- Focus on Neuromodulation and Pelvic Health

Experience Requirement:
- Minimum of two years of relevant work experience; internship experience may be considered

Work Arrangement:
- Flexible schedule: 3 days onsite, 2 days remote

The Product Engineer II operates under general supervision to deliver global product release support and guidance for the execution of design for release product engineering (RPE) initiatives.

This role also provides necessary support for the introduction of new products (NPI) as required.


A Day in the Life:
- Analyze, troubleshoot, and apply technical skills to RPE initiatives while also supporting NPI projects as needed.
- Participate in the planning and coordination of engineering projects, generating necessary project documentation.
- Monitor project progress and contribute to enhancing operational efficiency.
- Create and finalize plans, reports, or other documentation in compliance with applicable procedures.
- Guide cross-functional partners in the area of product release strategy and execution.
- Offer technical knowledge and project direction to global teams supporting common processes and systems.
- Assist in developing solutions to meet business objectives for product release.
- Facilitate cross-functional alignment in Configuration Management, Development, and related Operations functions.

Key Responsibilities:
- Oversee production support engineering concerning testing methods, device specifications, and yield challenges.
- Manage device responsibilities post-transfer into high-volume production, typically overseeing all device manufacturing operations aside from wafer fabrication.
- Assist customers with device usage issues or testing of complex devices.

Qualifications:
- Bachelor's degree in engineering or a technical field with at least 2 years of relevant experience, or a Master's degree with 6 months of relevant experience.

Preferred Qualifications:
- Experience in a regulated environment, particularly in medical devices.
- Familiarity with FDA, ISO, EN, and/or GMP standards.
- Strong attention to detail and ability to adapt to shifting priorities.
- Proficiency in common software applications (e.g., Word, Excel, Adobe Reader).
- Demonstrated ability to work independently and collaboratively within a team.
- Involvement in process definition and improvement initiatives.
- Formal training in Product Data or Lifecycle Management systems.
- Capacity to learn and adapt to evolving technologies, processes, or requirements.

Specialist Career Stream:
- Typically an individual contributor responsible for a professional discipline or specialty, managing assigned projects and collaborating with stakeholders to achieve desired outcomes.

Autonomy:
- Works independently with general supervision on larger, moderately complex projects.

Organizational Impact:
- Sets objectives for own job area to align with project goals and contributes to project milestones.

Innovation and Complexity:
- Problems encountered are generally straightforward, requiring a broader understanding of related issues.
- Makes adjustments or recommends enhancements to systems and processes to improve effectiveness.

Communication and Influence:
- Primarily communicates with internal contacts; external interactions are less complex.

Leadership and Talent Management:
- May provide guidance to entry-level professionals or employees in support roles.

Required Knowledge and Experience:
- Practical knowledge and demonstrated competence typically obtained through advanced education combined with relevant experience.
- Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with no experience.