Sr. Design Assurance Specialist

Why Join Bracco Medical Technologies?

We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way.Each member of the Bracco Medical Technologies team has the power to make a difference......every day!

Primary Duties & Responsibilities:

Design Assurance

• Consults to ensure that high quality products are designed and manufactured by BMT. May provide expertise, training and/or consulting in Quality processes and methods to build and maintain a quality-oriented culture.
• Contributes to the generation and upkeep of risk management documentation as part of product development projects.
• Performs periodic updates to product risk management documents. This may include but not limited to analysis of complaint data, PSURs, risk management plan/reports, FMEAs, BRAs, and PHSRs.
• Coordinate interactions between design assurance and the medical advisory board.
• Develop and implement improvements to quality system processes. This may include actions resulting from CAPAs, quality plans, or audit findings.
• Develop and maintain product knowledge of existing and new products.
• Participate on project teams (product development, sustaining, and sourced finished medical device) and completing items as assigned.

Post-Market Surveillance

• Provide support for the Annual Global Post-Market Surveillance Reports
• Provide Global Complaint Data for input to Annual Clinical Evaluation reports, Annual Risk Reports, Health Risk Assessments, Failure Modes Effects Analysis (FMEA), Fault Tree Analysis
• Partnering with Post-Market Surveillance to incorporate products into the Post-Market Surveillance complaint database.
• Perform data analysis and data reporting limited/full market release product surveillance and other data requests as needed (Clinical, Regulatory Affairs, R&D).
• Partners with cross-functional teams to fulfill global Post-Market Surveillance, Clinical Evaluation, and Risk Management reporting requirements.

Qualifications (Knowledge, Skills & Abilities):

Minimum

• BA or BS degree, or a combination of education and medical device experience providing equivalent knowledge
• 5 years medical device industry experience
• 3 years Quality experience in the medical device industry
• Working knowledge and experience with ISO 13485, 21CFR 820, and EU Medical Device Regulation
• Familiarity with 21 CFR 803 Medical Device Reporting and ISO 14971 Risk Management.
• Must have excellent verbal and written communication skills, initiative, flexibility, creative thinking and the ability to understand the underlying technical principles of ACIST products
• Must also have the ability to work with individuals at all levels of the corporation in a congenial and cooperative manner
• Experience working on cross-functional teams
• Ability to develop clear, concise, and timely oral and written reports.
• Must have organized and effective work habits.
• Proficient personal computer skills including Microsoft Office, database activity, word processing, spreadsheet, graphics, etc.

Preferred:

• Experience with minimally invasive medical devices
• Experience with TrackWise, Agile, SAP or other validated software used in quality management systems
• Experience working with post-market complaint data, risk management records, and risk management reports

Other:

• Mental demands - work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations.
• Travel requirements are minimal. Total travel expected to be less than 5% annually.

Compensation & Total Rewards:

Estimated Starting Salary Range: $98,000 - $107,000

*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.

Total Rewards:

• Paid Time Off, Company Holidays & Paid Family Leave- We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve- Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well- We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve- Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
• Choose- You won't find "stuffy" here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.

Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.