Senior Scientist Biosensor Jobs (NOW HIRING)

Job Type
Full-time
Description
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The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers . While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq's careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites.
About the Company
Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.
Job Purpose
This is a key Manager role responsible for leading, and managing the Complaint department, ensuring compliance with global regulatory requirements. This highly visible role will work closely with Customer Service and Technical Support and be responsible for reviewing Customer Feedback/Complaints and identifying reportable events. They will work with cross-functional teams of engineers in chemistry, software, hardware, manufacturing, and quality to develop investigative tools and techniques for complaint investigations.
This role requires significant attention to detail, excellent verbal and written communication skills, and the ability and critical thinking skills to prioritize competing projects.
Duties and Responsibilities

• Develop and implement strategies for handling product complaints, including investigation, reporting, and corrective actions
• Evaluate complaints for reportable events in the US and international agencies
• Utilize an electronic complaint handling and event reporting system. Manage electronic Medical Device Reports for US reportable events
• Oversee the monitoring and trending of complaint data to identify potential product issues and implement preventive measures
• Create a culture of continuous improvement, consistently focused on providing service that adds value to the customer experience
• Demonstrated experience in leading complaint teams in high growth start-ups or established high volume medical device corporations
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Product Development to ensure alignment on technical support and vigilance activities
• Maintain up-to-date knowledge of industry standards and regulatory requirements for medical device complaints/vigilance
• Prepare and present reports to senior management on activities and key performance metrics

Requirements
Qualifications

• Bachelor's degree required, advanced degree desired in a Biological, Chemistry, Quality, Engineering or related discipline
• Minimum of 8 years of experience in medical device or biotech industry
• Minimum of 4 years of experience in Technical Support and Complaint Vigilance in a medical device or biotech setting; FDA and ISO regulated industry, MDSAP and or MDR experience a plus
• In-depth knowledge of global regulatory requirements for medical device complaint vigilance, including FDA and EU MDR regulations
• Experience with electronic quality management systems as well as paper-based systems
• Proven leadership experience with a track record of managing teams and complex problems is essential
• Strong analytical skills and the ability to interpret complex data are crucial
• Excellent communication and interpersonal skills are necessary to effectively present information and respond to questions from various stakeholders

Working Conditions

• Work on-site in an open office environment

BENEFITS
Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.
At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.
As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $125,000 to $145,000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.
Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at Careers@biolinq.com
Salary Description
$125,000-$145,000