Job Title: Senior Operations Engineer
Our team is looking for a skilled Senior Operations Engineer to join our dynamic and results-oriented group. As a key member of our engineering team, you will be responsible for executing the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology, and procedures required for the manufacture of new products.
You will use the latest engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and quality standards. Your responsibilities will include providing engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with our company's procedures.
Key Responsibilities:
* Provide engineering support for new product and process introductions
* Ensure quality of process and product as defined in the appropriate operation and material specifications
* Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements
* Work with quality engineers to develop component-specific testing and inspection protocols
* Support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation
* Analyse equipment to establish operating data, conduct experimental tests, and result analysis
* Lead and/or participate in process review meetings
* Participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product transfers and launches
* Complete capability studies for in-process inspection and generate subsequent inspection documentation
* Conduct MSA studies for new products and new processes
* Provide training for manufacturing team members
* Ensure adherence to GMP and safety procedures
* Review and approval of validation documentation
* Assume overall responsibility for the successful initiation, planning, design, execution, monitoring, controlling, and closure of a project
Required Skills and Qualifications:
To succeed in this role, you will need:
* B.S in Mechanical Engineering or related engineering discipline with 2 or more years' experience
* Knowledge of New Product Introduction is desirable
* Self-starter with demonstrated efficient work methods, analytical, and problem-solving skills and ability to handle multiple tasks in a fast-paced environment
* Demonstrated Leadership, Project Management, and Engineering experience in New Product Introduction in a regulated environment would prove beneficial
* The individual should enjoy working in a fast-paced, dynamic, and results-oriented team environment
* Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams
* Innovative thinker - should be able to envisage new and better ways of doing things
* Excellent analytical skills, ability to plan, organise, and implement concurrent tasks
* Good knowledge of manufacturing processes, materials, product, and process design
* Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing
* Experience in an FDA-regulated or regulated industry beneficial
* High level of PC Skills required
* Excellent attention to detail
Benefits:
This role offers a unique opportunity to join our dynamic team and contribute to the success of our organisation. If you are a motivated and experienced engineer looking for a new challenge, we encourage you to apply.
Others:
Please note that this role will be posted for a minimum of 3 days. To be considered for this role, you will be redirected to and must complete the application process on our careers page.
],