Process Development Engineer IV (Staff)

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    

Responsible for activities and area goals   through design, development, and transfer at the component and finished product level;

Duties and Responsibilities

•  Support R&D on identifying critical to quality attributes (CQAs), test development, characterization, and specifications;
• Validate critical in-process test methods to demonstrate suitability for intended use;
• Identify opportunities to scale and automate test methods for capacity and capability;
• Develop trace matrix linking user needs, design, inputs, and system and sub-system requirements to process specifications (PSD);
• Identify “leap” technologies enabling scale, demonstrate proof of concept and business case, and down-select for implementation into manufacturing pipeline;
• Manage equipment lifecycle through requirements (URS, ERD), concept, site acceptance (FAT, SAT), and induction (EB, IQ);
• Develop processes, fixtures, and equipment that meet business and manufacturing needs;
• Design experiments to baseline, characterize, and optimize process variables;
• Define preventative maintenance and setup procedures for new equipment;
• Develop test plan, qualification templates, and risk assessments for process validation; 
• Complete initial line qualification activities to support regulatory filing and product launch (MVP, OQ/PQ/PV)
• Develop production control plan to monitor product consistency in manufacturing;
• Develop pilot manufacturing layout and cell design for product flow;
• Support delivery of pre-commercial builds for unreleased product or process iterations;
• Release documents for build traceability of new product or process iterations (MPI, DHR);
• Provide capital requirements for capacity and budget planning;
• Integrate lessons learned and opportunities from current product into future generations;
• Provide input to ensure product is designed for manufacturability and assembly (DFM);
• Maintain repository of key insights and tribal knowledge for sustaining engineering team; 
• Characterize noise factors (storage, environment, etc.) and process cliffs for scaling robustness;
• Collaborate with R&D and Supply Chain to model product cost for anticipated volumes;
• Assess viability of product and process to meet manufacturing and business needs; 
• Document engineering tradeoffs and deferred changes for process transfer;
• Complete supporting documents for design transfer (DHF, DMR, etc.);
• Provide technical input for product- and manufacturing-related non-conformances, risk management, and manufacturing strategy;
• Re-evaluate manufacturing release criteria for yield and/or performance improvement;
• Participate in review meetings to align on production performance and strategic initiatives;
• Implement new manufacturing equipment to support scaling, including at key suppliers; 
• Execute strategic initiatives to increase capacity and meet anticipated scaling needs;
• Implement advanced manufacturing strategies to support maturation of technologies and competencies needed for high-volume manufacturing;
• Design or modify equipment and fixtures to mitigate variation sources in manufacturing;
• Complete change impact assessment to align implementation plan for proposed changes;
• Evaluate and implement 2nd source materials for manufacturing supply risk;
• Develop qualification process to evaluate performance of incoming raw material lots;
• Support evaluation, selection, development, and qualification of key suppliers;
• Develop test methods and material specifications for critical components;
• Characterize product impact of sterilization, shipping, and storage for commercial flexibility;

Requirements

Qualifications     

• BS Degree in Mechanical   Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required
• Minimum 8-12 years related experience, including years of higher-level education (MS, PhD)
• Experience in design of   experiments and statistical tools (ANOVA, t-test, etc.)
• Experience with Fishbone, A3, 5Y, and other root cause investigation tools
• Strong understanding of process interactions (inputs, outputs) that are both technical and system related
• Expertise with scaling manufacturing processes to commercial volumes
• Experience with budgeting, cost management, modeling, and preparing business proposals (ROI, NPV) for new initiatives seeking executive approval
• Strong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standards
• Experience with lean manufacturing and six sigma methodologies (preferred)
• Experience with design for manufacturability concepts and product development lifecycle (preferred)
• Experience with standard electrical, mechanical, and wet lab test equipment (preferred)
• Strong leadership skills, including the ability to set goals, allocate resources to appropriate   priorities, and provide constructive feedback to foster positive relationships
• Proficiency in Microsoft Office tools
• Proficiency with JMP, Minitab, or equivalent statistical software
• Experience with ERP, MES, and other manufacturing systems
• Proficiency in BMRAM or equivalent asset management system
• Expertise in several specialty skillset, including injection molding, welding, analytical chemistry, microscopy, metrology, adhesives, or electronics packaging
• Proficiency in Solidworks or equivalent CAD software (preferred)
• Experience with MS Project, Visio, and other project management tools (preferred)
• Experience with manufacturing database, controls, and vision (preferred)
• Experience with Altium or other electronics design software (preferred)
• Role model for what kindness looks like. Actively levels up those on the team through example setting, guidance, and support. Empowers others to make effective decisions
• Excels at identifying solutions to accelerate team’s learning of the problem space
• Strong organizational planning and ability to hold others accountable. Breaks down silos within and across teams to ensure forward progress and collective success
• Ability to take decisive action and deliver tangible results in a cross-functional organization. Leadership aptitude of teams, projects, and programs

Working Conditions

General Office, Laboratory, and   Cleanroom environments

Expected travel less than 10%

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 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: $130,000 to $145,000.  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 [email protected]