Engineer IV, Manufacturing Research

POSITION SUMMARY:

This position will play a critical role in supporting high-impact research initiatives at MSD related to the research and development of manufacturing methods for clinical consumables. This position will work with a team of engineers and scientists to design and evaluate novel and high throughput manufacturing techniques for next generation diagnostic consumables, and eventually work closely with an internal automation team to scale up to high volume production. The role involves close collaboration with both internal departments and external partners to drive innovation and achieve research objectives.

DUTIES AND RESPONSIBILITIES:

• Lead a multidisciplinary team in the research and development of new high-volume manufacturing methods for consumables.

• Guide the consumable design process to be highly scalable and high quality.

• Develop and prototype systems for consumable manufacturing and inspection.

• Make and guide key technical decisions throughout research and development activities.

• Perform hands-on work as part of active experimental programs.

• Prepare and present project designs and technical reports as needed.

• Create and/or update manufacturing and project documents and procedures.

• Work with Quality to ensure products are manufactured and/or assembled according to quality guidelines.

• Ensure compliance with relevant regulatory standards.

EXPERIENCE AND QUALIFICATIONS:

• Bachelor’s degree in Biology, Chemistry, Biotechnology, Engineering or related field is required

o Master’s degree in a similar field is preferred

• Minimum 10 years of experience in high throughput plastic manufacturing.

• Minimum 5 years of experience manufacturing biological products preferred.

• Experience with cGMP and/or ISO certification is preferred.

• Supervisory experience preferred.

• Desirable skill sets may include but not be limited to the following:

o Manufacturing immunoassays and/or reagents o In-vitro diagnostic devices and consumables

KNOWLEDGE, SKILLS AND ABILITIES: • Deep experience with several of the following manufacturing methods at scale: o Roll-to-Roll processing and converting o Sheet-to-sheet or sheets-on-shuttle processing

o Plastic film and metal foil processing techniques:

 Bonding (thermal, ultrasonic, laser, adhesive, solvent)

 Forming (stamping, thermal embossing, drawing, ultrasonic)

 Cutting (laser, knife)

o Liquid integration (Blister packs design and formation or similar)

 Plastic vapor barriers (materials and methods)

 Liquid addition and sealing

 Lyophilized reagent addition and sealing

o Coating techniques such as:

 Liquid and ink: Slot Die, micro gravure, Meyer rod, ink jet, spray coating, screen printing, and dip coating

 Vacuum based: sputtering and evaporation o Biological handing and coating

• Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.

• Ability to lead and guide staff to meet department goals.

• Demonstrated critical thinking and analytical skills, as well as the ability to handle complex situations and demonstrate sound judgment and problem solving.

• Excellent oral, written communication and interpersonal skills.

• A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding research environment with changing priorities.

PHYSICAL DEMANDS:

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT:

This position will operate in the following areas of the organization:

• Traditional office environment;

• Chemistry and BSL-1/BSL-2 lab environment;

• Engineering prototype and production space