Engineering Jobs in Moncure, NC

Do you have a passion for helping design and manufacture innovative medical and drug delivery devices that can improve lives? At Gilero’s Pittsboro, NC location, we are looking for a Design Transfer Engineer to help lead our mission-driven team with purpose and dedication, fostering inclusivity and teamwork to create innovative solutions for patients and customers.

Design Transfer Engineers draw on experience to oversee and champion the development and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

In this role, you would manage technical risks and ensure high-quality outcomes, ensuring seamless collaboration with customers, vendors, and internal teams. You would also mentor junior engineers, promoting excellence and future success. The work of a Senior Design Transfer Engineer should have a sense of pride, characterized by curiosity, attention to detail, and organizational excellence.

Responsibilities

• Act as a technical support, increasing the rigor of technical product development, with project support of products, accessories, and cross-functional initiatives
• Manage product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer
• Support sustaining engineering activities for products in commercial manufacturing
• Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
• Maintain Device Master Record (DMR) and ensure documents are complete, accurate, and current including process routers, inspection plans, temporary deviations, and nonconformances
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes
• Support the quotation process for engineering projects and commercial manufacturing
• Facilitate design transfer of existing products to and from other manufacturing sites
• Track technical risk and provide engineering guidance
• Seek feedback and mentorship from senior engineers
• Help lead the development team through technical risk retirement. Support the team on technical risks through step-by-step simplification to discover root cause
• Create, review, and release documents according to Gilero’s QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements
• Keep project managers informed on technical projects variables and status
• Prepare documentation to support design history files and regulatory submissions
• Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals)
• Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
• Support delivery of project objectives and milestones
• Participate in testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements
• Support product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering
• Write and execute protocols for design verification and validation
• Support test method development and validation
• Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds
• Support investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering
• Investigate, evaluate, and research competitive devices and product materials/designs

Skills/Qualifications:

• BS in Engineering or equivalent technical degree
• 1+ years relevant working experience in product development, 2+ preferred. Medical device or combination product experience preferred
• Skilled at transforming technical situations into well-defined project deliverables
• Understanding of good GDP
• Understanding of the Phase Gate System
• Exposure and understanding of ISO 14971, 13485 and CFR 21 Knowledge base
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing
• Ability to support and document appropriate scenarios for rationale-based decisions versus testing-based approaches
• Ability to author scientific/logic-based rationale
• Awareness of pre-clinical validation and GLP
• Ability to review and understand technical drawings and GD&T to support development lifecycle
• Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc)
• Excellent communication skills (oral and written)

Personal Attributes:

• Meets Gilero Core Values:
• Collaboration - embracing teamwork and transparency in our organization, partnering with our customers and vendors
• Integrity - doing the right thing at all times; fair and trustworthy; always keeping the patient in mind
• Innovation - open to new ideas, processes, and solutions; leveraging technology to creatively solve problems
• Excellence - delivering exceptional products and services with passion and pride
• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking
• responsibility for core activities and providing high-quality service to internal and to external clients
• Commitment to excellence and quality service to external and internal customers
• Follow established policies and procedures, while contributing to continuous improvements

Eligibility To Work:

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero, we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company-provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.

Featured benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Disability insurance

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.