Process Development Engineer IV (Staff)

• 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

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.

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 Careers@biolinq.com