R&D Manager - Medical Device & Life Science

Job Type


Full-time

Description

Join Weiss-Aug - A Leader in Precision Manufacturing and Innovation

Be part of a company that's shaping the future of manufacturing where your ideas, skills, and passion matter.

Weiss-Aug, is a leading provider of advanced manufacturing and engineering solutions with advanced facilities across the U.S. and Mexico for over 50 years.

Why Join Us?

At Weiss-Aug we are driven by a commitment to excellence, innovation, and continuous improvement. As a recognized leader in the industrial and commercial sectors, specializing in high-volume metal stamping, thermoplastic molding, and value-added assembly solutions our Weiss-Aug MedPharma serves the medical device and life science industry, offering unparalleled vertically integrated manufacturing solutions, partnered with in-house product design and engineering services. These combined capabilities provide Weiss-Aug a strategic advantage over the competition, being able to offer our customers a true, single-source supplier option, to meet their most challenging product innovation needs.

As we continue to push the boundaries of what is possible, including our latest advancements in materials science, specialty coatings, laser processing, and hybrid additive manufacturing technologies - Weiss-Aug MedPharma needs the best minds in industry. Expanding our team is paramount, bringing in fresh perspectives, ideas and broad-based talent to further enhance our solution offerings, driving new growth and supporting our technology roadmap - including the release of finished drug-delivery / combination devices and machined implants.

We're currently seeking a passionate and skilled R&D Manager to join our team and contribute to our mission of delivering high-quality, engineered solutions to our customers worldwide. In this role you will be responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following: program management and measurement of machined product and fixtures/tooling, progressive stamped parts, and tooling, insert molding parts and tooling, factory assembled automation, and other related tooling/processes.

Responsibilities:

• Represent the customer in order to ensure that the customer's expectations are clearly understood and being met.
• Provide leadership to technical teams responsible for successful launch of multiple complex programs.
• Service and grow our program base within the Medical / Life Science Industry (Technical Sales)
• Responsible for overseeing the coordination and on-time/in-budget completion of all projects which may involve some or all of the following: program management and measurement of machined product and fixtures/tooling, progressive stamped parts and tooling, insert molding parts and tooling, factory assembled automation, and other related tooling/processes.
• Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE's, FMEA's, Process Flowcharts, Control Plans, Capability Studies and Gage R&R's.
• Ability to participate in product design (R&D) meetings with Medical Customers in relationship with Weiss-Aug Manufacturing technologies.
• Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities, monitor progress and report status to management/customer.
• Facilitate Tooling Kickoff, Specification Review, Design Review and Lessons Learned (Post Mortem) Meetings.
• Oversee the development and input of initial BOM and detailed Routing
• Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation.
• Execute Engineering Studies on Existing and New Programs to facilitate and part optimization and debug.
• Create and define methods for simulation of assemblies to support "end of line" quality.
• Involvement in the management of key suppliers as required by projects. Interface with outside suppliers to ensure they provide product or services on-time and to quality specifications.
• Identify and facilitate new and/or special equipment needs along with Manufacturing Engineering.
• Interface with customer on technical and schedule-related issues. Ensure program progress is communicated to customer at regular intervals.
• Mediate conflicts between departments. Forge compromise and consensus between team members.
• Assist in identifying areas for continued improvement and opportunities to gain organizational knowledge.
• Participate in customer, internal and registrar quality system audits in support of in-process inspection and new program qualification.
• Investigate and determine root cause(s) for internal and external complaints and/or quality rejections. (DPD, DPA's, 8D's, DMR)
• Lead or participate in trouble shooting of existing and new processes.
• Create and maintain process documentation. Train personnel as it relates to process documentation and procedures.
• Perform any and all tasks of direct and indirect reports to ensure deadlines are met or exceeded.
• Motivate and develop team members.
• Ability to understand top level asks, translate and set team direction to accomplish company goals.
• Must be driven self-starter that works with little supervision.
• Must possess the ability to multi-task and set priorities.
• Jointly responsible for successful transfer of tooling to Manufacturing along with Toolroom and Design Engineering functions.
• Oversee the selection and management of key suppliers as required by project. Oversee the completion of requisitions for approval by management for purchased tooling or other product or services. Interface with outside suppliers to ensure they provide product or services on-time and to specifications.
• Assist in determining needs for additional personnel and/or training in order to meet program needs.
• Manage program risks by considering tradeoffs between time, cost, customer needs and product and manufacturing physics.
• Support Sales and New Product Development Teams. May assist in identifying potential leads and opportunities.

Requirements

• Requires a 4-yr engineering, technical or management degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
• Minimum of 5 yrs. experience in program management/technical project management and/or manufacturing and/or product design (R&D) environment. Experience in medical device/life science industry required.
• Experience with product design, program/project management, and understanding of tight-tolerance manufactured products is required.
• Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning preferable.
• Ability to use SolidWorks for product/tooling design preferable.
• Knowledge of quality inspection tools and methods preferable. Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
• Knowledge of GMP/ISO Quality Systems required.
• Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.
• Knowledge of machined product, progressive metal stamping and/or insert molding processes desirable.
• Participate actively in a team-oriented environment. Provide leadership to cross-functional teams whenever necessary with ability to lead in all areas of a manufacturing organization.
• Ability to support Technical Sales and grow our program/customer base in the Medical Industry.
• Proficient in Microsoft Project. Able to create Gantt charts including: creation and linking of tasks, assigning of resources, tracking of tasks, and progress reporting.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Knowledge of Plex or MRP or ERP software preferable.
• Exceptional analytical and computational skills. Knowledge of problem-solving tools and techniques preferable.
• Excellent verbal and written communication skills.
• Demonstrated high level of negotiation and conflict-resolution skills.
• Demonstrated high level of creativity and innovation.
• Demonstrated decision-making capability.
• Demonstrated customer interfacing skills, including "soft skills" needed to facilitate technical sales.
• Must possess good analytical and problem-solving skills and mechanical aptitude.

This position is at our Fairfield, NJ location.

Salary : $120,000 - $150,000 per year

Other Benefits Include

• Medical, Dental and Vision
• 401 (k) with company match
• Holiday, Vacation and Sick Time
• Tuition Reimbursement
• Health Savings Accounts (HAS)
• Flexible Spending Accounts (FSA)
• Cigna Wellness Incentive Program
• Employee Assistance Program (EAP)
• Short Term Disability
• Group Life and Accidental Insurance
• Sun Life - Accident, Critical Illness, and Hospital Indemnity Insurance
• Smoking Cessation Program
• Pet Insurance

US Pay Transparency


The base salary for this role will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills, experience, and internal consistency.

If your salary requirements exceed the advertised range and you remain interested in Weiss-Aug, we encourage you to apply.

Weiss-Aug is an Equal Opportunity/Affirmative Action Employer. Applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other characteristics protected by applicable federal, state, or local law.