Engineer III, Process

POSITION SUMMARY

This position is responsible for leading the development, characterization and validation of manufacturing processes to produce biochemical assay plates and related consumables. This position may provide day to day guidance to others.

DUTIES AND RESPONSIBILITIES:

* Provide input to the management team to identify, develop, and execute departmental initiatives and strategies.

* Lead technical team(s) to accomplish project goals and manages/coordinates work of other team members.

* Enhance existing manufacturing processes and implement new manufacturing processes to ensure high quality production, reduced lot-to-lot variability, expanded product portfolio and enhancements to manufacturing capacity.

* Design, conduct, supervise and review process experiments on manufacturing and pilot scale equipment to determine the impact of material properties and process variables on product properties.

* Work with suppliers to improve product quality and lot-to-lot reproducibility of purchased raw materials.

* Collaborate with other departments to ensure peak product performance.

* Support the corporate validation effort as required for ISO certification and FDA approval.

* Write and review SOPs, validation protocols and validation reports.

* Document and present experimental results in accordance with company procedures.

* Specific duties may vary depending upon departmental requirements.

EXPERIENCE AND QUALIFICATIONS

* Bachelor's in chemical/biochemical engineering or a related field.

* Six to eight years related experience in manufacturing of instrumentation or related field.

* Experience in quality standards such as GMP, ISO 9001 and ISO 13485 is required.

* Supervisor experience is preferred.

KNOWLEDGE, SKILLS AND ABILITIES

* Expert knowledge of process development techniques (such as process optimization, process control, design of experiments) and statistical analysis.

* Expert knowledge of screen printing, assembly and coating techniques, fluid dispensing, drying/desiccation techniques, protein stabilization, electrochemiluminescence and image analysis techniques.

* Familiarity with assay development and QC techniques.

* Attention to detail with demonstrated commitment to excellence and performance.

* Strong analytical skills with the demonstrated ability to gather and evaluate complex data and information and develop a recommendation and plan of action.

* Ability to work independently, as an effective team member, and with all levels of the company.

* Demonstrated ability to move project tasks forward in an orderly and structured fashion.

* Excellent oral, written communication and interpersonal skills.

* Proficiency with the MS Office Suite (including MS Project) and Minitab.

* Demonstrated ability to multi-task and work productively in a demanding research environment with changing priorities.

* Solid leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results.

• Ability to travel locally.

PHYSICAL DEMANDS

This position requires the ability to communicate and exchange information, utilize manufacturing and laboratory equipment, and move about the office and manufacturing floor.

WORK ENVIRONMENT

This position will spend time in a Clean Room environment, with some travel between local office sites.

COMPENSATION SUMMARY:

The annual base salary for this position ranges from $101,400 to $154,650. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY:

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO/AA STATEMENT:

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.

Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.