Senior Automation Engineer

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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:

Responsible for activities and area goalsthrough design development qualification deployment and sustaining of automation equipment and production fixtures at the component and finished product level.

Duties and Responsibilities

• Support R&D and Manufacturing Engineering with development of fixtures and automation solutions enabling product and process development;
• Develop processes fixtures and equipment that meet business and manufacturing needs;
• Design prototype evaluate and deploy robust fixtures for process characterization engineering builds verification activities and manufacturing scale-up;
• Identify opportunities to automate manual processes to improve quality capacity repeatability and cost;
• Develop user requirements and equipment specifications (URS ERD) for automation equipment and fixtures;
• Manage equipment lifecycle through requirements development design review FAT/SAT qualification deployment and sustaining support;
• Partner with external automation vendors and system integrators to develop equipment concepts schedules budgets and implementation plans;
• Lead technical reviews of automation system architecture controls mechanical design software safety systems and validation strategy;
• Review equipment and fixture designs to ensure manufacturability serviceability operator usability and scalability;
• Develop risk assessments qualification protocols acceptance criteria and preventative maintenance requirements for equipment and fixtures;
• Design experiments to characterize and optimize equipment fixtures and process performance using standard engineering and statistical methods;
• Partner with Quality and Validation teams to support equipment qualification activities;
• Complete root cause investigations related to equipment tooling automation systems and process performance andimplement sustainable corrective actions;
• Optimize equipment and fixture designs to improve quality efficiency capacity and process repeatability at the lowest cost;
• Develop capital plans and cost models to support automation investments capacity expansion and manufacturing scale-up;
• Support evaluation selection development and qualification of automation suppliers integrators and manufacturing partners;
• Manage automation project execution with external vendors to ensure delivery of scope schedule budget and performance objectives;
• Develop business processes standards and tools that improve equipment deployment manufacturing execution and automation capability;
• Provide the voice of manufacturing and automation to ensure successful transfer from R&D into production and future product generations

• BS Degree in Mechanical Engineering Manufacturing Engineering Electrical Engineering or scientific discipline required;
• Minimum 8-12 years related experience including years of higher-level education (MS PhD);
• Experience specifying designing implementing and qualifying automated manufacturing equipment and fixtures;
• Experience leading automation projects through requirements development design review build FAT SAT and deployment;
• Experience with design of experiments (DOE) statistical analysis and root cause investigation methodologies;
• Strong understanding of process interactions system interaction and manufacturing process control;
• Expertise scaling manufacturing processes equipment and automation systems to commercial volumes;
• Experience with capital planning cost analysis and business case development (ROI NPV);
• Strong understanding of FDA 21 CFR Part 820 ISO 13485 and equipment validation requirements;
• Experience with industrial automation technologies including controls PLC/HMI systems robotics machine vision sensors and equipment integration;
• Experience with lean manufacturing six sigma and design for manufacturability principles (preferred);
• Strong leadership skills with the ability to influence cross-functional teams prioritize resources and drive execution;
• Proficiency in Microsoft Office and project management tools;
• Proficiency in BMRAM or equivalent asset management system;
• Proficiency in SolidWorks or equivalent CAD software;
• Experience with manufacturing databases MES and industrial control systems (preferred);
• Strong organizational problem solving and decision-making skills with a proven ability to deliver results across teams projects and programs

Working Conditions

General Office Laboratory and Cleanroom environments

Expected travel less than 20%

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 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: $110000 to $125000 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