Description

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 Summary

We are seeking an experienced and enthusiastic technical lead to join the team at Biolinq. This individual will be responsible for developing the technical strategy, planning and executing systems analysis and characterization of next gen Biolinq systems. They will provide technical oversight through data analysis, test method development and execution. They will work closely with R&D and Operations to correlate bench and in-vivo data. They will provide significant contributions to long   range strategy and product transfer into production. This individual must be a highly motivated team player who is looking to grow with a rapidly growing company.   

Duties and Responsibilities

• Responsible for systems analysis and characterizing of Biolinq analyte monitoring systems
• Planning and executing hypothesis driven feasibility testing, data analysis, and insight generation 
• Process large clinical and bench datasets using state of the art methods
• Working closely with rest of R&D, Clinical, Manufacturing, and Regulatory on product development, verification, and validation 
• Collaborate with key stakeholders in R&D, Operations, and Quality to ensure that requirements are testable and measurable
• Own DV&V testing strategy including sample sizes, acceptance criteria, and testing sequence
• Review dFMEAs to ensure appropriate design controls are implemented 
• Train and coordinate project resources to assure data integrity and maximize testing throughput
• Proactively identify roadblocks and implement mitigations to minimize disruptions to program timeline
• Create gap assessment documentation to leverage previous verification testing for design changes
• Develop solutions for technical issues using systematic problem-solving and engineering best practices 
• Investigate and address root causes of failed or anomalous units
• Explain test method losses and deviations to approved test plans and protocols
• Work with senior leadership and team to achieve corporate goals and KPIs

Requirements

• PhD in Technical discipline highly preferred.  Advanced degree and equivalent experience will also be considered.  
• 7-12 years’ related experience in product development, system testing, and design transfer within medical device industry
• Hands on experience with designing and executing bench experiments.  
• Proficiency in statistics and data analysis methods (t-test, ANOVA, GR&R)
• Proficient in statistical packages such as Jmp and Python to run analyses on large amounts of data 
• Ability to take decisive action and deliver tangible results in a cross-functional and fast-paced organization 
• Ability to condense complex requirements into specific and measurable test objectives
• Ability to navigate ambiguity and take on new challenges
• Experience in building and leading teams, projects, and programs
• Excellent internal and external communication & interpersonal skills
• Experience in developing and delivering executive level & customer presentations
• Working under FDA and ISO 13485 regulations is preferred 

Working Conditions and Travel Requirements

General Office and Laboratory

Expected travel less than 10%

Physical Requirements

While performing the duties of   this job, the employee is regularly required to stand; walk; sit; use hands to   handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may   occasionally lift/or move up to 15 pounds

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 commitment to diversity, equity, and inclusion, 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: $150,000 to $180,000.  We may ultimately pay more or less than the posted range.  Actual compensation packages are 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