Engineering Manager, NPI

About the company:Viant is a global medical device partner providing design development manufacturing and assembly services through capabilities in materials plastics metals extrusion and automation. With nearly 6000 employees across 24 locations worldwide it delivers high-quality life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medicals website or on : Eligible for benefits effective date of hire!Medical dental and vision benefitsCompany-paid life insurance and disability benefitsGenerous Paid time off and 10 paid Holidays401k Plan with Company MatchTuition ReimbursementVoluntary Universal Life and Long-Term CareVoluntary Legal PlanPet InsuranceHome Ownership ProgramAbout the site:Our Wheeling facility combines precision machining and assembly capabilities to deliver high-quality medical device components and finished the role:The NPI Engineering Manager will lead and develop the Engineering team with primary responsibility for New Product Introduction (NPI) product industrialization and process development. This role is accountable for successfully transferring new products from concept and design into production by establishing robust manufacturing processes validation strategies and scalable production systems. The NPI Engineering Manager will partner closely with customers Operations Quality Manufacturing and Supply Chain to ensure new products meet safety quality delivery and cost objectives while supporting long-term business growth. This role will primarily support metal-centric medical device products and manufacturing processes. Additionally this leader will collaborate with the site leadership team to grow partnerships with new and existing customers by promoting a culture of consistently meeting or exceeding customer expectations through Continuous Improvement Operational Excellence and High-Performance offer market competitive compensation. Potential salary range for this role is $135k-$150k. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by youll do:Lead NPI activities from concept through commercialization production launch and stable handoff to engineering resources project priorities timelines and budgets to support customer development programs business growth initiatives and manufacturing directly with customers and internal teams on Design for Manufacturability (DFM) Design for Assembly (DFA) technical reviews risk assessments quoting support and design transfer and implement robust manufacturing processes for medical device components and assemblies with emphasis on metal-centric technologies such as CNC machining Swiss turning precision grinding laser processing metal forming finishing and secondary process characterization Design of Experiments equipment qualification process development and validation activities including IQ OQ PQ and controlled Engineering Studies when supported by approved cross-functional teams to execute product launches within established safety quality delivery cost and budget manufacturing readiness plans addressing equipment tooling fixtures gauges inspection methods work instructions capacity staffing supply chain and production and implement new manufacturing technologies automation solutions capital equipment andtoolingto support product requirements and future business NPI activitiescomply withViant Quality System requirements FDA regulations ISO standards customer requirements and EHS lean manufacturing risk management and project management methodologies to improve engineering execution and accelerate commercialization customer and product requirements into scalable manufacturing solutions that deliver capable processes quality performance and operational accountability innovation collaboration and continuous learning within the engineering team development through coaching performance reviews succession planning and alignment with Viant values and career growth opportunitiesRequirementsEducation/Certification/Experience:Bachelorof science degreeinEngineeringor related discipline advanced degreepreferred7years of engineering experience in a regulated manufacturing environment preferably within the medical device industry.4 years ofdemonstratedpeopleleadership technical leadership or project leadership including responsibility for engineering teams and cross-functional experience leading NPI product industrialization process development design transfer validation and commercialization with metal-centric manufacturing processes and knowledge of FDA ISO OSHA and applicable quality-system Strong leader clear communicator and highly organized project manager with the ability to manage multiple customer programs and competing interpersonal conflict-resolutionteam-building and influencing skills across technical operational and customer-facing understanding of design transfer manufacturing process development process validation product commercialization and production ramp-up within a regulated Quality understanding of FDA and ISO requirements applicable to medical device development and recordof creative problem solving risk reduction and successful product experience with process characterization Design of Experiments capability analysis and statistical methods including t-tests ANOVA and significance technical documentation including engineering reports risk assessments protocols IQ/OQ/PQ documentation Engineering Studies SOPs and work Microsoft Office Excel and Six Sigma Green Belt preferred; Black Belt certification is a provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race color religion gender sexual orientation national origin age disability marital status amnesty or status as a covered veteran in accordance with applicable federal state and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.