Senior Manufacturing Engineer - ICONMA : Job Details

Our Client, a Medical Device and Healthcare Company, is looking for Senior Manufacturing Engineer for their Syracuse, NY/Remote location Responsibilities:

• Senior manufacturing engineer - (Process) will project manage, lead, and support third party manufacturers to deliver robust injection molding solution.
• This will include the definition, selection of the right technology, specification, purchase, installation, and qualification of plastic injection molding, metrology, processing equipment in accordance with internal and external regulatory requirements.
• Drives tooling and molding equipment activities at the supplier(s) to ensure that production start-up through to scale up to increased volumes are achieved within requirements.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Lead and facilitate design / specification, purchase, installation and qualification of mould tools, moulding machines, ancillary equipment, and service requirements for their installation.
• Understand the business needs of the company and have a thorough understanding of customer and clinical needs as they relate to projects.
• Demonstrate strong and clear accountability / responsibility for successful and timely.
• completion of designated project deliverables.
• Design and lead complex experiments, often with multiple variables; independently execute and/or direct others in the execution of project tasks by applying novel engineering theories, concepts, and techniques.
• Working closely with the project team and third-party manufacturers to ensure required support is provided to meet project objectives.
• Work closely with all key stakeholders to develop metrology methods.
• Conceptualize complete solutions; create or coordinate the design solutions for novel or complex problems; explore multiple alternatives.
• Serve as subject matter expert (SME) or independent technical expert (ITE) on a project's technical matters; may interface with senior management, external firms or agencies; may coordinate technical matters between organizations.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures, rules and regulations.
• Responsible for implementing and maintaining the effectiveness of the Quality System.

Requirements

• Bachelor's degree (preferably in Polymer Engineering, Polymer science) or a closely related discipline is desired) or equivalent technical experience and demonstrated competence required; additional post-graduate education may contribute toward the desired years of experience.
• Typically requires 8+ years of significant engineering and / or operational experience to develop the
• competence required to meet the skills and responsibilities of the position.
• Expertise in Plastic injection molding technologies, mold tool designs and process
• Development in third-party manufacturing environment.
• Effective communication, presentation, and documentation skills.
• Problem analysis, fault finding on injection mold tools and equipment.
• Design of Experiment for plastic injection molding process development.
• Structured and controlled working practices with clear and accurate documentation, reporting
• and presentation skills.
• Good level of engineering, validation, and process development knowledge.
• Risk analysis with sound understanding of FMEA process.
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
• Strong understanding GD&T and design of metrology fixtures
• Ability to work independently and in groups; ability to work cross-functionally.
• Ability and aptitude to use various types of databases and other computer software.
• Strong organizational and project management skills in third-party manufacturing environment.
• Ability to quickly gain knowledge, understanding or skills and is willing to learn.
• Prior Experience of analyzing First Article Inspection (FAI) and process capability data
• Experience in work with tooling manufacturing sites including interacting with toolmakers suppliers for design & FAT qualification activities.
• Familiarity with cGMP, FDA and ISO regulated environment
• Experience with instrumentation molding for process control would be an advantage.

Additional Notes From Hiring Manager:

• Must have Bachelor's degree ~ mentioned Polymer is preferred but will consider Science or Engineering degree works.
• Arts types of degrees will not be considered.
• Will be working in a technical role at an Client site that is a 3rd party molding supplier.
• Minimum of 5+ years of experience. looking for a candidate who knows about tooling and molding process.
• Will need to know how molding works, how to run parts and make sure the parts are qualified.
• Must have good Project Management skills with managing timelines, dates and deliverables and keeping everything on track.
• Does not require a PMP cert. Must have Validation activities knowledge and skills with IQ, OQ and PQ. Will be reviewing all validation docs to determine if meets requirements.
• Medical device exp. required.
• Manager wants someone who can hit the floor running.
• Manager will be looking mainly for type of experience AND years of experience.
• No overqualifications.

Top 3 Skills:

• Project management exp. (no PMP required)
• Support validation activities
• Make sure can get right support when needed

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.