Full-Time Senior Manufacturing Engineer
Job Description
Note : This is an onsite role from Day 1. We don’t have any flexibility/option for remote work here.
Position Summary
The Senior Manufacturing Engineer will be working on medical device development as part of a tight knit development team. This role will be designing and developing a new manufacturing area for assembly and post-process of parts for our flag-ship product. You will be expected to develop manufacturing processes from the ground-up and to provide continuous feedback on the development process and accept feedback as well. You will be expected to own all parts of the process, from incoming part inspections to assembly quality, to out-going checks. The ideal candidate would have work experience in being a part of an engineering team and building a medical device. We are looking for a team player who views medical device development as a competitive advantage. We are a rapidly growing business with opportunity for the right candidate to continue advancing their role and responsibilities as the company grows. Ability to adapt in a fast-paced environment is a must.
Core duties and responsibilities include the following
- Work closely with design engineers to design and optimize assembly process of multiple products and subsystems.
- Utilize precision manufacturing and assembly process to manufacture robotic systems. Be a hands-on member of the team in building
- Design manufacturing area layout, define necessary tooling and procedures for efficient and high- quality assembly.
- Create and review PFMEA, create control plans, implement appropriate mitigations, and run process validation for FDA regulated medical device.
- Define and design quality inspection processes for incoming, pre-assembly, post-assembly, and out-going. Ensure all process are followed and implement continuous improvement.
- Support design reviews, develop assembly fixtures and assessment manufacturing readiness.
- Create, develop, and improve work instructions for new products and create manufacturing process documentation
- Create appropriate manufacturing KPIs, utilize cost-benefit-analysis to justify new equipment and change to manufacturing processes.
- Role may require some travel
Education and Experience
- BSc. in Mechanical, Aerospace, Biomedical Engineering or in an equivalent area
- 10+ years of experience in the field.
- Experience in developing work instruction, control plans, process validation
- Medical device development
- Design experience precision automation
- Competency in precession assembly, cable management and quality inspections.
- Proven leadership in a hardware manufacturing setting and ability to implement processes
- Analytical problem solution skills, such a Measurement System Analysis and DOE.
- Working with teams in multiple sites
- Familiarity with PPAP process, Six-Sigma and DMAIC
- Familiarity with 3D CAD software such as SolidWorks
- Graduate degree in a related field with dissertation
- Additive manufacturing, such as 3D printing
MUST HAVE
- BSc. in Mechanical, Aerospace, Biomedical Engineering or in an equivalent area
- 10+ years of industry experience preferably in Aerospace or Automotive. and other related sector.
- Well versed with electronic devices/electromechanical devices.
- Should be a hands-on person.
- Experience in leading the setup of a Production line/Manufacturing Line.
- Prior experience in managing a manufacturing team of atleast 10 to 12 people.
- Medical device development experience is a huge plus.
