Quality Assurance Product Engineer
2 weeks ago
JOB DESCRIPTION
We are seeking a dedicated and skilled Product Engineer II to join our team. Below are the key details regarding this position:
Essential Skills:
- Experience in quality engineering and adherence to quality processes.
- Background in packaging engineering, particularly in designing final pack configurations.
- Proficiency in Microsoft Excel, Word, SharePoint, OneDrive, and Teams.
Main Responsibilities:
- Assist in the design of final pack configurations and setup of new end item configurations.
- Provide release support, including managing product release checklists and authorizations for both physical products and software.
- Address ad hoc requests related to end items and product releases.
Product Focus:
- This role will primarily support products in the Neuromodulation and Pelvic Health sectors.
Experience Requirements:
- A minimum of two years of relevant work experience is preferred, although internship experience may be considered.
Work Arrangement:
- The position offers a flexible work schedule, with three days onsite and two days remote.
The Product Engineer II will operate under general supervision, providing global product release support and guidance for the execution of design for release product engineering programs. This role includes supporting the release of new product introduction programs as needed.
In a typical day, you will analyze and troubleshoot RPE programs, participate in project planning and coordination, and generate necessary project documentation. You will also monitor project progress and contribute to enhancing operational efficiency.
As part of your responsibilities, you will provide direction and strategy execution to cross-functional partners regarding product release, while offering technical knowledge and project direction to global teams. Your support will be crucial in developing solutions that meet business objectives for product release.
In addition, you will assist in defining the direction for new products and processes by implementing solutions to complex challenges. You will oversee production support engineering related to product configurations and ensure compliance with quality procedures.
Qualifications:
- A Bachelor's degree in engineering or a related technical field with at least two years of job-related experience, or a Master's degree with six months of relevant experience.
Preferred Qualifications:
- Experience in a regulated environment, particularly within the medical device industry.
- 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.
- Demonstrated capability to work independently and collaboratively within a team.
- Involvement in process definition and improvement initiatives.
- Formal training in Product Data or Lifecycle Management systems.
Additional Responsibilities:
- Oversee production support engineering, including testing methods and device specifications.
- Assist customers with device usage issues and complex testing.
Career Development:
- This role typically involves individual contributions within a professional discipline, managing projects and collaborating with stakeholders to achieve desired outcomes. You may also mentor junior colleagues or direct the work of less experienced professionals.
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