- 经验
- 3+ yrs
- 薪水
- —
- 职位空缺
- 1
- 发布
- 1 小时前
- Work mode
- 在家办公
- 学历
- Bachelor's Degree in Mechanical Engineering
- Eligibility
- Candidates with a bachelor’s degree in Mechanical Engineering and at least 3 years of relevant mechanical engineering experience in product development are eligible. Experience in regulated environments is beneficial, and the position is open to applicants who can work remotely from the United Stat…
- Resume
- Required to apply
职位描述
Role Overview
This is a fully remote Mechanical Engineer position focused on product development support across the full lifecycle. The role contributes to design, verification, validation, documentation, risk management, and cross-functional execution in a regulated environment.
Required Qualifications
- A bachelor’s degree in Mechanical Engineering is mandatory.
- You should bring at least 3 years of experience in mechanical engineering within a product development setting.
- Hands-on exposure to the Product Development Lifecycle (PDLM) is needed.
- Experience with Design Failure Mode and Effects Analysis (DFMEA) is required.
- You must have supported design verification and validation work.
- Strong capability in technical documentation and engineering change management is essential.
Preferred Qualifications
- Prior exposure to the medical device industry is highly desirable.
- Experience in FDA-regulated or similarly regulated environments is preferred.
- Working knowledge of Creo for mechanical design and engineering documentation is an advantage.
- Experience with SAP, especially for engineering documents and document control, is preferred.
- Familiarity with Windchill will be considered a plus.
Key Responsibilities
- Contribute to DSx product development work across the complete product lifecycle.
- Take part in and help lead DFMEA sessions and broader risk management efforts.
- Plan, carry out, and properly record verification and validation testing.
- Prepare and update technical documentation in line with quality and regulatory expectations.
- Work closely with engineering, quality, regulatory, and manufacturing functions.
- Investigate technical problems and support root-cause analysis.
- Assist with design reviews and initiatives aimed at continuous improvement.
Interview Process
- The selection process consists of a single interview round held on Microsoft Teams with the hiring manager.
- Discussion topics will include problem-solving, DFMEA exposure, regulated product development experience, communication approach, and handling multiple priorities.
Additional Information
This role is remote and based in the United States. No salary or stipend details were provided.