- 经验
- 3+ yrs
- 薪水
- —
- 职位空缺
- 1
- 发布
- 1 小时前
- Work mode
- 杂交种
- 学历
- B.Tech
- Eligibility
- Candidates with a bachelor’s degree in Mechanical Engineering and at least 3 years of relevant product development experience are eligible. Experience in medical devices, FDA-regulated environments, Creo, SAP, or Windchill is preferred but not mandatory.
- Resume
- Required to apply
职位描述
Overview
This role is for a Mechanical Engineer working on product development in a regulated environment. The position follows a hybrid schedule with 3 days on-site and 2 days remote each week.
Work Arrangement
- Hybrid model: 3 days in the office and 2 days working remotely.
Required Qualifications
- A bachelor’s degree in Mechanical Engineering is mandatory.
- At least 3 years of hands-on mechanical engineering experience within a product development setting.
- Practical exposure to the full Product Development Lifecycle (PDLM).
- Experience conducting Design Failure Mode and Effects Analysis (DFMEA).
- Background supporting design verification and validation efforts.
- Strong capability in technical documentation and engineering change control.
Preferred Qualifications
- Experience in the medical device industry is highly desirable.
- Prior work in FDA-regulated or similarly controlled environments is a plus.
- Familiarity with Creo for mechanical design and documentation is preferred.
- Working knowledge of SAP, especially for engineering documents and document handling, is valued.
- Exposure to Windchill would be an added advantage.
Key Responsibilities
- Contribute to DSx product development work across the entire product lifecycle.
- Facilitate and take part in DFMEA sessions and broader risk management activities.
- Plan, carry out, and record verification and validation testing.
- Prepare and update technical documents in line with quality and regulatory standards.
- Work closely with engineering, quality, regulatory, and manufacturing stakeholders.
- Investigate technical problems and support root-cause analysis.
- Assist with design reviews and continuous improvement efforts.
Additional Information
This position is based in Queens County, NY. The role is full-time and remote/hybrid in nature. No salary figure, number of openings, or start date was provided.