Design Assurance Engineer

Key Responsibilities

General

• Completes work assignments under limited supervision/guidance.
• Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
• Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
• Identifies and resolves complex exceptions to work assignments.
• Seeks to support improvements in product and process quality.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Excellent interpersonal and communication skills with good leadership abilities.

Technical

• Provides both quality and technical input to commercial product activities.
• Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
• Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
• Excellent analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.

Leadership

• Is an active team member completing quality deliverables associated with BSC’s sustaining engineering (commercial product) support.
• Is a fully motivated team member - achieves and demonstrates best practices in line with set objectives.
• Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.

Qualifications & Experience

• HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 3-4 years’ experience in a similar role.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.