Andover Ma: Medical Device Quality Software Consultant – Onsite (233278)

This position is accountable for supporting new product development for complex electromechanical medical devices. This person will support design control, risk management and human factors from product inception through product launch while ensuring products meet regulatory requirements, quality standards consistent with company policies.

Responsibilities

• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
• Support Risk Management activities (RMP, HA, DFMEA, PFMEA, UFMEA and RMR).
• Responsible for establishing, communicating, and mitigating risk throughout the product development process
• Participate in design reviews
• Support safety assurance case creation in compliance with the regulatory requirements.
• Review and approve human factors documentation such as use specifications, task analysis, formative and summative studies protocols and reports.
• Performs other related duties and responsibilities, on occasion, as assigned
• Support design test and inspection method development, and lead method validation activities
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
• Provides guidance to cross-functional development team(s) in approach to design control documentation.
• Review, and approve design control deliverables such as requirements, specifications, validation protocols and reports to ensure compliance to customer and regulatory requirements.

Experience And Education

• 5+ Years of experience in design controls and risk management
• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and ISO 14971
• B.S. degree, in a scientific, technical, or engineering discipline.
• Clear and professional communications to all levels of the organization are important in this role and you will have well-developed written and oral communication skills.
• Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter
• Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.
• Must possess excellent oral and written communication skills, and the ability to communicate appropriately with cross functional teams
• Strong technical and problem-solving foundation
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.
• Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations.
• You work independently as well as collaboratively with cross functional teams.

Andover MA: Medical Device Quality Software Consultant – Onsite (233278)

About Black Diamond Networks

Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.