Skills & Qualifications
- Bachelor's Degree in Mechanical Engineering
- Approximately 0 - 2 years of professional experience.
- Will be considering entry level candidates with a degree in Mechanical Engineering for this role.
This role will support remediation of technical documentation, design requirements, and validation evidence to support compliance of class I and class II respiratory medical devices and accessories to the European Medical Device Regulation going into effect in 2020.
- Apply basic risk and resources assessment skills when considering opportunities for change. The role is expected to collect basic information needed to analyze a problem, situation or issue.
- Follows and observes all regulatory and Quality Management Plan requirements (GMPs, ISO, FDA, Internal policies) applicable to area of responsibility
- Non-conformance resolution of specific issue and performing or implementing the containment, bracketing, root cause investigation, and corrective action.
- Initiate Engineering Change Request (ECO's) to implement changes to production documents such as drawings, bills of materials, and procedures.
- Create and update engineering and production documents including procedures, drawing, bill of lading, and work instructions.
- Candidates will be debriefed on the project day 1 and will be expected to dive into the role immediately thereafter.
- Candidates will be required to meet specific project deadlines based on review of several thousand sku's.
- Best candidate will have worked within a regulated industry in the past in manufacturing.
- Entry level candidates with a degree in mechanical engineering will be considered.
- This company manufactures and markets more than 27,000 unique products for the diagnosis, treatment and monitoring of respiratory conditions in every stage of life.
- They are a singular, focused company offering products in four areas: respiratory diagnostics, ventilation, airway management and operative care consumables.
Manufacturing Engineering responsible for designing, developing, and sustaining manufacturing processes to meet or exceed operational performance expectations.
- Demonstrate basic knowledge of Manufacturing Engineering principles and technologies supporting production delivery targets and supporting gross margin improvement projects
- Improve production line efficiency and yield improvements utilizing Lean principles and tools, evaluating and improving process capability, and creating workflows that minimize work in progress and inventory.
- Serve as a credible resource to others; answers basic questions pertaining to a specific area of expertise
- Learn ERP systems and the financial and logistical interactions of work orders, drawings, Bill of Materials, cost of goods sold, and standard hours
- Meaningfully impact the company's short-term and long-term success
- Work closely with site leadership teams and cross-functional departments
- Work closely with suppliers
- Be a key player in a high impact project