Staff Manufacturing Engineer, NPD

embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit? ~~~ ?or follow our social channels on? LinkedIn ,? Facebook ,? Instagram ?and? Twitter .

The Staff Manufacturing Engineer will be responsible for leading technical engineering activities both internally, as well as with key strategic partners, throughout new product development (NPD) projects. They will identify and implement technical solutions to complex manufacturing challenges, leveraging robust engineering principles and industry best practices. Manufacturing processes may include heat staking, laser welding, catheter tipping, ultrasonic welding, chemical bonding and others. This position will also provide leadership within NPD projects and be able to provide technical direction, incorporating DFMA principles.

Responsibilities:

• Lead the development and optimization of processes to understand key process inputs and outputs, using statistical methods such as DOEs as appropriate. Executes new process equipment and tooling development, including specification development, vendor selection and negotiation.

• Assist/conduct design reviews of product components, product assemblies, manufacturing fixtures and tooling.

• Execute process validations (IQ, OQ and PQ). Write protocols and reports to support verification and validation activities for product commercialization.

• Prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications and drawings.

• Update or develop new test methods in conjunction with OPS and R&D personnel. Prepare and assist in the validation of test methods.

• Train technicians on new design and process development changes as well as new test methods. Assist/conduct new process development training with operations and quality assurance.

• Mentor and provide guidance to Manufacturing Engineers and technicians. May lead or manage technicians or engineering interns. Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines as a subject matter expert.

• Assist in design and process root cause analysis and support non-conforming product and complaint investigations.

Required Education and Experience:

• B.S. degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering or other related engineering disciplines.

• 8 years of experience in a manufacturing or NPD setting.

Required Qualifications:

• Experience with heat staking, laser welding, catheter tipping, ultrasonic welding, chemical bonding or similar assembly technologies.

• Advanced hands-on technical aptitude.

• Demonstrated ability to lead cross-functional teams from a technical perspective.

• Excellent oral and written communication skills.

• Detail oriented, checks own work, keeps accurate records and organizes information effectively.

• Ability to tolerate ambiguity, multiple priorities and short deadlines.

Preferred Qualifications:

• Knowledge of cGMP, GLP and/or experience in the medical device industry.

• Training in Six Sigma, Design for Six Sigma or DFMA.

• Experience working in a manufacturing plant.

embecta is an Equal Opportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.