Associate Production Engineer
1 month ago
Planet Innovation (PI) is a globally recognised Healthtech Innovation and Manufacturing company. PI offers the full spectrum of product design, engineering and manufacturing services for its customers in the diagnostics, life sciences and healthcare industries. Our clients include many of the world's top medical device companies, as well as some of the world's most exciting medtech start-ups.
With HQ in Australia and the majority of its customers in the US, PI established a world-class manufacturing facility in Irvine, California in 2021 and this division is growing rapidly on the back of high demand for our production services by both existing and new clients.
PI has an authentic, transparent, supportive culture and we offer a broad array of comprehensive benefit programs for our employees, including medical, dental, vision, 401k with employer match, and paid vacation, holidays, and sick leave.
As part of our continuous growth, we are looking for an energetic and enthusiastic Associate Production Engineer to join our manufacturing site in Irvine.
This is an onsite role.
The Role
- An Associate Production Engineer is responsible for supporting activities which contribute to the establishment and improvement of manufacturing processes for a range of technically complex products (both medical and non-medical devices).
- They are engaged in the manufacturing support of products to ensure product quality and delivery targets are achieved. This includes identification of opportunities for improvement, root cause analysis of issues and implementation of effective solutions.
- An Associate Production Engineer shall collaborate with SMEs from Engineering, Manufacturing and Quality to improve processes as a liaison for Production Technicians on the floor.
The Accountabilities
- Contribute to the establishment and lead the sustaining engineering effort of manufacturing processes
- Participate in and lead initiatives to improve the manufacturing process with a focus on lean assembly and workflow
- Manage issues and reports from line leads and technicians in an agreed and timely manner
- Preparation of reports of key metrics
- Support management of specific supplier issues / NCPs , SCAR and CAPA within the QMS
- Development of plans, schedules improvements for review and approval by manager
- Investigate, troubleshoot and implement new and improved /optimized assembly and manufacturing processes
- Prepare samples or prototypes as required for testing or other evaluations
- Management of relevant engineering documentation (e.g. product drawings, process flow charts, BOMs and SOPs)
- Participate in assembly processes within the manufacturing plant
- Assist with assessment and qualification of suppliers
- Ensure compliance with ISO9001 and ISO13485 manufacturing processes
- Interfacing with engineers, suppliers and customers (as required)
- Other duties as required commensurate with your skills and experience
The Typical Experiences
- 2+ years of experience within a medical device manufacturing facility
- Bachelor's Degree in engineering (in appropriate discipline i.e. Mechanical; Electronics; Technology)
- Knowledge of lean assembly and manufacturing techniques
- Knowledge of statistical process control
- Skilled in technical troubleshooting and problem solving
- Knowledge of change management (ECR/ECN, Change Control)
- Compliance with PI policies, procedures and international quality standards, including ISO13485, ISO9001 or having worked in a regulated industry
To Apply
A positive, high-achieving work culture, and plenty of opportunities to learn and grow await you at Planet Innovation, so apply now.
We are proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees, and all suitably qualified applicants will receive consideration for employment without regard for race, gender, sexual orientation, religion, disability, or age.
Please note only applications with the right to live and work in the US will be considered for these positions.
No recruitment agencies, please.
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