Manufacturing Engineer I
The Manufacturing Engineer I at Confidential Client supports production operations by providing technical expertise to improve manufacturing processes, equipment, and quality. This entry-level role involves collaborating with cross-functional teams to implement process improvements, lead equipment qualification, and ensure adherence to quality and safety standards within a medical device manufacturing environment. The engineer contributes to continuous improvement initiatives aligned with the company's Manufacturing Excellence and Innovation strategies.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Medical Device Manufacturing (CDMO).
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Overview
Confidential Client is hiring a Manufacturing Engineer I to support manufacturing and process engineering at their Alden, NY facility. This entry-level, full-time role focuses on day-to-day technical support of production lines, process and equipment improvements, process validation, and maintaining manufacturing documentation and MES configuration.
What You’ll Do
- Provide technical support to production associates and resolve day-to-day manufacturing issues.
- Develop, detail, and implement process and equipment solutions to improve safety, quality, delivery, and cost.
- Develop and procure tooling, fixtures, and equipment to optimize productivity and maintainability.
- Create and maintain manufacturing documentation and digital operations systems (engineering drawings, BOMs, routers, work instructions, engineering change orders, MES configuration).
- Lead equipment qualification and process validation activities.
- Collaborate with R&D, Quality, Supply Chain and cross-functional teams to influence designs for manufacturability and support product transfers.
- Investigate and support disposition of non-conforming products and participate in complaint investigations and DPRA/CAPA activities when required.
- Execute corrective and preventative action plans and support continuous improvement projects using standard problem-solving methods.
- Monitor equipment and process performance; adjust parameters or escalate issues to maintain yield and product quality.
- Support supplier-change evaluations that may impact product design and manufacturing processes.
- Perform other duties as assigned by your line manager.
How You’ll Be Measured
- Adherence to safety, environmental, and quality programs.
- Achievement of defined goals and project milestones.
- Contribution toward site Quality KPIs and continuous improvement ideas.
- Successful execution of equipment qualifications, validations, and design transfers.
- Active participation in Manufacturing Excellence initiatives and standard work deployments.
Qualifications
- Bachelor’s degree in Engineering or a related technical field and 0–3 years of relevant experience.
- Candidates without the degree may be considered with 5+ years of relevant manufacturing engineering experience.
- Basic knowledge of manufacturing processes, tooling, and equipment used in medical device production.
- Familiarity with Quality Management Systems (QMS), FDA regulations, and production documentation practices.
- Experience or coursework in process validation, equipment qualification, and root cause analysis preferred.
- Working knowledge or exposure to MES, IIOT systems, BOMs, and CAD/engineering drawings is a plus.
- Strong verbal and written communication skills; ability to collaborate across functions.
- Positive, solutions-focused attitude and ability to work in a fast-paced production environment.
Compensation & Benefits
- Salary range: $61,500 - $90,200 per year (source range from the posting).
- Market estimate shown on source: ~$93,064 per year (estimated).
- Total rewards include base salary plus cash-based incentive programs, comprehensive medical/dental/vision coverage, disability and life insurance, adoption benefits, 401(k) with company match, paid time off and company-designated holidays, and optional voluntary benefits (supplemental life, critical illness, hospital indemnity, accident insurance). Parental leave available after one year.
About Our Client
Confidential Client is a leading contract development and manufacturing organization (CDMO) serving medical device markets including cardiovascular, neuromodulation, and cardiac rhythm management. The site in Alden, NY follows rigorous QMS and regulatory practices and emphasizes engineering-driven manufacturing excellence.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
Negotiate a higher salary! Check the salary ranges for this job type in your area.
View My Salary Range